Drug recall · FDA · Published February 9, 2018
American Pharmaceutical Ingredients LLC recalls Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall notice
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Contact the company & request your remedy
Recalling firmAmerican Pharmaceutical Ingredients LLC6650 Highland Rd Ste 302, N/A · Waterford, MI 48327-1665
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
We’re still writing up this recall
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
Source Page by GovInfoNow · govinfonow.com/recall/40817-american-pharmaceutical-ingredients-llc-recalls-nifedipine-usp-for-prescription-compounding · Recall date February 9, 2018 · FDA enforcement record: FDA #D-0513-2018
Cite this page
“American Pharmaceutical Ingredients LLC recalls Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g.” GovInfoNow, recall dated February 9, 2018. https://govinfonow.com/recall/40817-american-pharmaceutical-ingredients-llc-recalls-nifedipine-usp-for-prescription-compounding. Based on FDA recall #D-0513-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0513-2018%22&limit=1).
How to tell if you have this one
- Brand
American Pharmaceutical Ingredients LLC- Category
Drug
All 66 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide within USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0474-2018 | Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.; Lot #: a) 031915-1, Exp. 12/31/2019; b) 031915-2, Exp. 12/31/2019; c) 031915-2, Exp. 12/31/2019; d) 031915-1, Exp. 12/31/2019. | 15000 g |
| D-0475-2018 | Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.; Lot #: a) 011116-1, Exp. 07/31/2020; b) 011116-1, 011116-2, Exp. 07/31/2020; c) 011116-1, Exp. 07/31/2020 | 684 g |
| D-0476-2018 | Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.; Lot #: a) 021816-2, 021816-3, Exp. 08/24/2018; 70616-1, Exp. 01/31/2019; b) 021816-1, Exp. 08/24/2018; 070616-1, Exp. 01/31/2019; c) 021816-1, Exp. 08/24/2018; 070616-1, Exp. 01/31/2019; d) 021816-1, Exp. 08/24/2018; 070616-1, exp. 01/31/2019. | 55500 g |
| D-0477-2018 | Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.; Lot #: a) 050715-2, Exp. 04/30/2019; b) 050715-2, Exp. 04/30/2019; c) 050715-1, Exp. 04/30/2019. | 10 g |
| D-0478-2018 | Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 080515-2, Exp. 06/05/2019; b) 080515-1, Exp. 06/05/2019; c) 080515-1, Exp. 06/05/2019; | 48525 g |
| D-0479-2018 | Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 042315-1, Exp. 03/12/2018; b) 042315-1, Exp. 03/12/2018 | 1300 g |
| D-0480-2018 | Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 25g (NDC 58597-8010-4); d)100g (NDC 58597-8010-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 070915-1, Exp. 12/31/2019; b) 070915-1, Exp. 12/31/2019; c) 070915-1, Exp. 12/31/2019; d) 070915-1, Exp. 12/31/2019 | 5000 g |
| D-0481-2018 | Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 081715-1, Exp. 2/29/2020; b) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; CBP1307004BVP-4102015, Exp. 4/30/2018; c) 010615-1, Exp. 6/30/2019; 081715-1, Exp. 2/29/2020 d) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; 081715-2, Exp. 2/29/2020; | 123900 g |
| D-0482-2018 | Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 062515-2, Exp. 02/28/2019; b) 062515-1, Exp. 02/28/2019; 062515-2, Exp. 02/28/2019; 052317B-2, Exp. 01/31/2021; c) 052317B-1, Exp. 01/31/2021; 052317B-1, Exp. 01/31/2021; 062515-1, exp. 02/28/2019; d) 052317B-1, Exp. 01/31/2021; 062515-3, exp. 02/28/2019. | 13335 g |
| D-0483-2018 | Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.; Lot #: 071015-1, Exp. 3/7/2018 | N/A |
| D-0484-2018 | Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 082715-1, Exp. 06/24/2018; 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; b) 082715-1, Exp. 06/24/2018; 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; c) 061715-1, Exp. 6/6/2018; 072516-2, Exp. 07/04/2019; 082715-1, Exp. 06/24/2018; d) 072516-1, Exp. 07/04/2019; 082715-1, Exp. 06/24/2018; | 116850 g |
| D-0485-2018 | Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 031715-1, Exp. 12/31/2019; b) 031715-1, Exp. 12/31/2019 | 8300 g |
| D-0486-2018 | Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 082815-1, Exp. 06/04/2019; b) 082417-1, Exp. 03/04/2020; 082815-1, Exp. 06/04/2019; c) 082815-1, Exp. 06/04/2019; d) 082815-1, Exp. 06/04/2019 | 75000 |
| D-0487-2018 | Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 061115-2, Exp. 05/31/2019; b) 061115-1, Exp. 5/31/2019; | 10000 g |
| D-0488-2018 | Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 111516-1, Exp. 09/19/2018; b) 011917A-1, Exp. 09/22/2018; c) 111516-1, Exp. 09/19/2018; d) 011917A-1, Exp. 09/22/2018; 111516-1, Exp. 09/19/2018; e) 011917A-1, Exp. 09/22/2018; 111516-1, Exp. 09/19/2018 | 2000 g |
| D-0489-2018 | Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot: #:a) 083017-1, Exp. 7/22/2022; b) 083017-1, Exp. 7/22/2022; c) 083017-1, Exp. 7/22/2022. | 4910 g |
| D-0490-2018 | Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327.; Lot #: a) 111516-1, Exp. 9/19/2018; 011817-1, Exp. 9/10/2018; 111616-1, Exp. 5/18/2018; 052317A-1, Exp. 5/27/2019; b) 011817-1, Exp. 9/10/2018; 111616-1, Exp. 5/18/2018; 052317A-1, Exp. 5/27/2019; c) 011817-1, Exp. 9/10/2018; 052317A-1, Exp. 5/27/2019; 111616-1, Exp. 5/18/2018; | 3675 g |
| D-0491-2018 | Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 052915-2, Exp. 05/05/2017; b) 052915-2, Exp. 05/05/2017; c) 052915-1, Exp. 05/05/2017. | 5000 g |
| D-0492-2018 | Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 051115-1, Exp. 4/30/2020; 081017-1, exp 11/30/2021; 122216-1,122216-2, Exp. 12/31/2020; b) 041017-1, Exp. 11/30/2021; 051115-1, Exp. 4/30/2020; 081017-1, exp 11/30/2021; c) 041017-1, 041017-2, Exp. 11/30/2021; 122216-1, 122216-2, exp. 12/31/2020 | 106200 g |
| D-0493-2018 | Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 062915-2, Exp. 04/30/2020; b) 022416-1, Exp. 11/30/2020; 062915-2, exp. 04/30/2020; 081215-2, Exp. 06/30/2020; c) 022416-1, Exp. 11/30/2020; 062915-1, Exp. 04/30/2020; 081215-1, Exp. 06/30/2020; d) 022416-1, Exp. 11/30/2020; 062915-1, Exp. 04/30/2020; 081215-1, Exp. 06/30/2020; 110415-1, Exp. 09/30/20120 | 193000 g |
| D-0494-2018 | Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 031116-7, exp. 03/31/2019; 112816-1, Exp. 03/01/2020 b) 011717-2, 051617-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-7, exp. 03/31/2019; 051215-1, exp. 03/05/2018; 063015-1, Exp. 05/19/2018; 092315-1, Exp. 07/17/2018; 111615-6, Exp. 08/27/2018; 112816-1, Exp. 03/01/2020; c) 011717-7, 011717-2, 051617-1, 082117B-1, Exp. 04/30/2020; ; 031116-2, 031116-4, 031116-5, 031116-7, Exp.. 03/31/2019; 051215-1, Exp. 03/05/2018; 092315-2, Exp. 07/17/2018; 111615-4, 111615-5, Exp. 08/27/2018; 112816-1, 112816-2, Exp. 03/01/2020; d) 011717-7, 051617-1, 082117B-1, Exp. 04/30/2020; 031116-1, 031116-2, 031116-3, 031116-4, 031116-6, 031116-7, Exp. 03/31/2019; 051215-1, 051215-3, Exp. 03/05/2018; 063015-2, Exp. 05/19/2018; 111615-1, 111615-2, 111615-3, Exp. 08/27/2018; 112816-2, Exp. 03/01/2020 | 606950 |
| D-0495-2018 | Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 081015-1, Exp 07/23/2018; b) 081015-1, Exp 07/23/2018; 111116-1, Exp. 10/05/2019; c) 081015-1, Exp. 07/23/2018; 111116-1, Exp. 10/05/2019 | 26500 g |
| D-0496-2018 | Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 012016-2, Exp. 11/30/2020; b) 012016-1, Exp. 11/30/2020; c) 012016-1, Exp. 11/30/2020; 012016-2, Exp.11/30/2020; | 1638 g |
| D-0497-2018 | Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 061515-1, Exp. 04/30/2020; b) 080316-1, Exp. 06/30/2021; 052317C-1, Exp 02/28/2022; 061515-1, Exp. 04/30/2020; c) 061515-1, Exp. 04/30/2020; 080316-1, Exp. 06/30/2021; 091216-1, Exp. 07/31/2021; d) 061515-1, 061515-2, exp. 04/30/2020; 080316-1, Exp. 06/30/2021; 091216-1, Exp. 07/31/2021 | 52000 g |
| D-0498-2018 | Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 102015-3, Exp. 07/31/2020; 081616-3R, Exp. 02/28/2021; b) 081616-3, 081616-3R, Exp. 02/28/2021; 102015-2, Exp. 07/31/2020; c) 081616-1R, Exp. 02/28/2021; 081616-1, Exp. 02/29/2021; 102015-1, 102015-2, Exp. 07/31/2020; d) 102015-1, Exp. 07/31/2020; 081616-1, Exp. 02/29/2021; 081616-1R, 081616-2R, Exp. 02/28/2021. | 191000 g |
| D-0499-2018 | Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 091115-1, Exp. 07/31/2020; 091115-2, Exp. 07/31/2020; b) 091115-1, Exp. 07/31/2020; c) 091115-1, Exp. 07/31/2020. | 4600 g |
| D-0500-2018 | Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 051916-1, Exp. 04/30/2019; 061015-1, Exp. 03/03/2018; 041216-2, Exp. 03/27/2019; b) 051916-1, Exp. 04/30/2019; 052517-1, Exp. 02/28/2022; 061015-1, Exp. 03/03/2018; c) 041216-1, Exp. 03/27/2019; 051916-3, Exp. 04/30/2019; 052517-1, Exp. 02/28/2022; 061015-1, Exp. 03/03/2018; d) 041216-1, 041216-3, Exp. 03/27/2019; 051916-2, 051916-3, 051916-4, Exp. 04/30/2019; 061015-1, Exp. 03/03/2018; | 225300 g |
| D-0501-2018 | Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 092415-1, Exp. 05/21/2018; b) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018; c) 092415-1, Exp. 05/21/2018; 122915-1, Exp. 05/15/2018 d) 092415-1, Exp. 05/21/2018; | 240 g |
| D-0502-2018 | Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 072616-1, Exp. 06/29/2019; b) 060115-1, Exp. 01/23/2018; 072616-1, Exp. 06/29/2019; | 36100 g |
| D-0503-2018 | Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 073115-1, Exp. 6/30/2020; b) 073115-1, Exp. 6/30/2020; | 5800 g |
| D-0504-2018 | Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 072915-1, Exp. 07/05/2019; b) 072915-1, Exp. 07/05/2019 | 10000 g |
| D-0505-2018 | Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 090517B-2, Exp. 11/17/2019; b) 090517B-2, Exp. 11/17/2019 | 75 g |
| D-0506-2018 | Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; b) 020116-2, Exp. 12/13/2020; 021115-1, Exp. 01/15/2020; 080415-1, Exp. 03/22/2020; c) 020116-1, 020116-2, Exp. 12/13/2020; 021115-1, exp. 01/15/2020; 080415-1, Exp. 03/22/2020; 082416-1, 082416-2 Exp. 01/31/2021. | 166000 g |
| D-0507-2018 | Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7); d) 1000 (NDC 58597-8019-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lots #: a) 110215-2, Exp. 09/30/2020; b) 110215-1, Exp. 09/30/2020; 082516-1, Exp. 05/31/2021; c) 110215-1, Exp. 09/30/2020; 082516-1, Exp. 05/31/2021; d) 110215-1, Exp. 09/30/2020; 082516-1, Exp. 05/31/2021. | 74000 g |
| D-0508-2018 | Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 110515-2, Exp. 09/30/2018; b) 110515-1, Exp. 09/30/2018; c) 110515-1, Exp. 09/30/2018. | 22900 g |
| D-0509-2018 | Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8021-2.; Lot #: 090517A-1, Exp. 09/13/2018 | 73 g |
| D-0510-2018 | Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8; Lot #: 081415-2, Exp. 05/03/2018 | 12000 g |
| D-0511-2018 | Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 120916-1, Exp. 10/31/2019; b) 120916-1, Exp. 10/31/2019 c) 120916-1, Exp. 10/31/2019; d) 120916-1, Exp. 10/31/2019. | 7000 g |
| D-0512-2018 | Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 012716-1, 012716-2, Exp. 01/12/2019; 110316-3, Exp. 09/21/2021 b) 012716-1, 012716-3, Exp. 01/12/2019; 110316-1, 110316-3, Exp. 09/21/2021; c) 012716-1, 012716-3, Exp. 01/12/2019; 110316-1, 110316-2, Exp. 09/21/2021; exp. 09/21/2021; d) 012716-1, 012716-3, Exp. 01/12/2019; 041717-2, Exp. 04/06/2022; 110316-1, 110316-2, Exp. 09/21/2021. | 86225 g |
| D-0513-2018 | Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 020615-2, Exp. 12/04/2018; b) 020615-2, Exp. 12/04/2018; c) 020615-1, Exp. 12/04/2018; d) 020615-1, Exp. 12/04/2018; 020615-2, Exp. 12/04/2018. | 44500 g |
| D-0514-2018 | Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 012616-2, Exp. 01/08/2019; b) 012616-1, Exp. 01/08/2019; 012616-2, Exp. 01/08/2019; c) 012616-1, Exp. 01/08/2019; 012616-3, Exp. 01/08/2019. | 24025 g |
| D-0515-2018 | Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 092515-1, Exp. 5/31/2020; b) 092515-1, Exp. 5/31/2020. | 29550 g |
| D-0516-2018 | Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 080315-1, Exp. 04/05/2018; b) 080315-1, Exp. 04/05/2018, c) 080315-1, Exp. 04/05/2018. | 6000 g |
| D-0517-2018 | Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 071117-1, Exp. 06/16/2020; b) 071117-1, Exp. 06/16/2020; c) 071117-1, Exp. 06/16/2020 | 20700 g |
| D-0518-2018 | Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 031115-3, Exp. 12/24/2019; b) 031115-3, Exp. 12/24/2019 c) 031115-3, Exp. 12/24/2019; 050815-3, Exp. 04/14/2020; d) 010716-1, 010716-6, Exp. 11/10/2018; 030116-4, Exp. 12/04/2018; 031115-2, Exp. 12/24/2019; 060116-9, Exp. 4/28/2019; 080416-1, 080416-4, Exp. 06/05/2019; 080615-4, Exp. 07/29/2020; 112015-6, Exp. 10/7/2018; 121916-7, Exp. 11/10/2018; e) 080615-5, Exp. 07/29/2020; 010716-4, 010716-5, Exp. 11/10/2018; 030116-2, Exp. 12/04/2018; 031115-5, Exp. 12/24/2019; 060116-1, 060116-4, 060116-5, Exp. 04/28/2019; 080416-1, 080416-2, exp. 06/05/2019; 112015-1, Exp. 10/07/2018; 121916-2,121916-3, 121916-6, Exp. 11/02/2019; f) 112015-5, Exp. 10/07/2018; 010716-1, Exp. 11/10/2018; 030116-3, Exp. 12/04/2018; 010716-1, 010716-2, 010716-3, 010716-8, Exp. 11/10/2018; 030116-1, 030116-3, 030116-4,030116-5, Exp. 12/4/2018; 031115-5, Exp. 12/24/2019; 060116-4, 060116-6, 060116-8, 060116-9, Exp. 04/28/2019; 080416-3, 080416-4, 080416-5, Exp. 06/05/2019; 112015-2, 112015-3, 112015-4,112015-6, 112015-7, Exp. 10/07/2018; 121916-1, Exp. 11/02/2019; 121916-3, 121916-4, 121916-5, 121916-7 121916-8, Exp.11/02/2019; g) 060116-2, 060116-3 060116-7, Exp. 04/28/2019. | 1,050,000 g |
| D-0519-2018 | Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 021317-4, Exp. 12/31/2021; b) 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp. 08/31/2020 c) 050115-3, 050115-4, Exp. 03/31/2020; d) 021317-3R, Exp 12/31/2021; 050115-2, 050115-3, Exp. 03/31/2020; 101915-3, 101915-4,101915-5, Exp. 08/31/2020; e) 021317-2R, Exp. 12/31/2021; 050115-2, exp. 03/31/2020; 101915-1, 101915-2,101915-5, Exp. 08/31/2020; f) 021317-1R, 021317-2R,021317-3R, Exp. 12/31/2021; 050115-1, 050115-2, Exp. 03/31/2020; 101915-1, 101915-2, Exp. 08/31/2020. | 307500 g |
| D-0520-2018 | Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 080616-1, 4/26/2019; b) 080616-1, 4/26/2019; c) 080616-1, 4/26/2019; d) 080616-1, 4/26/2019. | 12300 g |
| D-0521-2018 | Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.; Lot #: 061615-1, Exp.12/31/2019 | 10000 g |
| D-0522-2018 | Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) SUT1213030SP-11192014, Exp. 11/30/2018; b) SUT1213030SP-11192014, exp. 11/30/2018; c) SUT1213030SP-7222015, Exp.11/30/2018. | 10000 g |
| D-0523-2018 | Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 053116-1R, Exp.04/30/2018; b) 053116-1R, Exp.04/30/2018 | 75 g |
| D-0524-2018 | Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 020717-3, Exp. 12/31/2021; b) 020717-2 020717-4, 020717-5 Exp. 12/31/2021; 092816-2, 092816-3, Exp. 07/31/2021; 121015-4, 121015-5, 121015-6, Exp.10/31/2020; c) 020717-1, 020717-4, 020717-5, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 092816-2, Exp. 07/31/2021; 121015-1,121015-3, Exp. 10/31/2020; d) 020717-1, 020717-2, Exp. 12/31/2021; 092816-1, Exp. 07/31/2021; 121015-2, Exp. 10/31/2020; e) 020717-1,020717-2 Exp. 12/31/2021. | 90000 g |
| D-0525-2018 | Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 071516-3, Exp. 04/01/2019; b) 071516-3, Exp. 4/1/2019; c) 071516-1, 071516-2, Exp. 04/01/2019; d) 071516-1, 071516-3, Exp. 04/01/2019, 032117B-1, Exp. 2/9/2020. | 33000 g |
| D-0526-2018 | Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 032117A-6, Exp. 01/21/2019; 112916-2, 112916-4, Exp. 10/17/2018; b) 032117A-4, 032117A-5, Exp. 01/21/2019; 112916-1, Exp. 10/17/2018; 112916-4, Exp. 10/17/2018; c) 032117A-1, 032117A-2, 032117A-3, 032117A-4, 032117A-5, Exp. 01/21/2019; 112916-1, 112916-2, 112916-3, 112916-4, Exp. 10/17/2018. | 611400 g |
| D-0527-2018 | Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 042016-2, Exp. 4/6/2019; b) 041217-1, Exp. 02/09/2019; 042016-2, 042016-3, Exp. 4/6/2019; c) 041217-1, 041217-3, Exp. 02/09/2019; 042016-1, Exp. 04/06/2019; 042016-2, Exp. 4/6/2019; d) 041217-3, Exp. 01/09/2019; 042016-1, Exp. 4/6/2019. | 47500 g |
| D-0528-2018 | Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) b) 032117C-1, Exp. 02/11/2020; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019; 071516-3, Exp. 4/1/2019; c) 032117C-1, Exp. 02/11/2020; 070716-1, Exp. 03/22/2019; 070716-2, Exp. 03/22/2019; 121616-1, Exp. 08/20/2019 d) 032117C-1, Exp. 02/11/2020; 061317-1, Exp. 4/30/2020; 061617-1, Exp. 05/01/2020; 070716-1, 070716-2, Exp. 03/22/2019; 121616-1, Exp. 8/20/2019. | 192000 g |
| D-0529-2018 | Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) UT2140602-1132014, Exp. 05/31/2019; b) UT2140602-1142014, UT2140602-4222015, Exp. 05/31/2019; UT2140602-10292014, Exp. 05/31/02019; UT2131205UI-1192015, Exp.11/30/2018; UT2140602-10292014, Exp. 05/31/2019; c) UT2140602-10282014, Exp. 05/31/2019; UT2131205UI, Exp. 11/30/2018; UT2140602-4222015, Exp. 5/31/2019; d) UT2140602-10282014, Exp. 05/31/2019; UT2131205UI, UT2131205UI-1192015, Exp. 11/30/2018. | 63975 g |
| D-0530-2018 | Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 062615-1, Exp. 06/09/2018; 071816-1, exp. 06/05/2019; b) 043015-1, Exp. 04/01/2018; 062615-1, Exp. 06/09/2018; 071816-1, exp. 06/05/2019; c) 062615-1, Exp. 06/09/2018; 071816-1, Exp. 06/05/2019. | 2100 g |
| D-0531-2018 | Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 071316-1, Exp. 05/27/2019; b) 071316-1, Exp. 05/27/2019 | 25000 g |
| D-0532-2018 | Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 013117-1, Exp. 06/30/2019; b) 013117-1, Exp. 06/30/2019; c) 013117-1, Exp. 06/30/2019. | 12725 g |
| D-0533-2018 | Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 070717-2, Exp. 05/31/2020; b) 070717-1, Exp. 05/31/2020; c) 070717-1, Exp. 05/31/2020; d) 070717-1, Exp. 05/31/2020. | 10000 g |
| D-0534-2018 | Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 072216-1, Exp. 11/26/2019; b) 072216-1, Exp. 11/26/2019; c)0 72216-1, Exp. 11/26/2019; | 50000 g |
| D-0535-2018 | Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: b) 030816-1, Exp. 05/20/2018; c) 030816-1, Exp. 05/20/2018; d) 030816-3, Exp. 05/20/2018; e) 030816-2, Exp. 05/20/2018; | 200000 g |
| D-0536-2018 | Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 070815-2, Exp. 04/24/2018; b) 070815-2, Exp. 04/24/2018; c) 070815-2, Exp. 04/24/2018; 110416-2, Exp. 06/30/2019; d) 110416-1, Exp. 06/30/2019; 070815-1, Exp. 04/24/2018. | 7255 g |
| D-0537-2018 | Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) b) 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019; 051515-3, Exp. 02/28/2019; c) 012216-1, Exp. 12/31/2019; 051515-3, Exp. 02/28/2019 d) 012216-1, Exp. 12/31/2019; 051515-2, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020; e) 051515-2, exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021; f) 012216-1, Exp. 12/31/2019; 051515-1, Exp. 02/28/2019; 061516-1, Exp. 01/31/2020; ; 082117A-1, Exp. 05/31/2021 | 10769 g |
| D-0538-2018 | Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 031815-2, Exp. 1/14/2020; b) 031815-2, Exp. 1/14/2020; c) 031815-2, Exp. 1/14/2020; d) 031815-1, Exp. 1/14/2020 | N/A |
| D-0539-2018 | Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327; Lot #: a) 052615-2, Exp. 4/30/2020; 020916-1, Exp. 12/31/2020; b) 092115-1, Exp. 8/31/2020; 092115-2, Exp. 8/31/2020; 020916-1, Exp. 12/31/2020; 110315-3, Exp. 9/30/2020; c) 020916-1, Exp. 12/31/2020, 110315-2, Exp. 9/30/2020; d) 020916-1, Exp. 12/31/2020 | N/A |
Contact American Pharmaceutical Ingredients LLC
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Subject: Recall D-0513-2018 — American Pharmaceutical Ingredients LLC American Pharmaceutical Ingredients LLC recalls Nifedipine Hello, I own a American Pharmaceutical Ingredients LLC recalls Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g that is covered by recall D-0513-2018 from American Pharmaceutical Ingredients LLC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0513-2018 (February 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0513-2018 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.