Partell Recalls Testosterone Pellets Due to Sterility Risk
Partell Specialty Pharmacy recalls Testosterone 40 mg pellets due to lack of sterility assurance. Check lot numbers and expiration dates for affected units.
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Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
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What happened, in plain English
Partell Specialty Pharmacy is recalling Testosterone 40 mg pellets packaged in amber vials because they were sterilized using a non-approved method, meaning sterility cannot be assured. The recall affects specific lots distributed only in Nevada. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/40724-partell-recalls-testosterone-pellets-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40724-partell-recalls-testosterone-pellets-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0666-2018
Cite this page
“Partell Recalls Testosterone Pellets Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40724-partell-recalls-testosterone-pellets-due-to-sterility-risk. Based on FDA recall #D-0666-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0666-2018%22&limit=1).
Why it’s dangerous
The product was sterilized using a method that has not been approved, so there is no guarantee that harmful microorganisms were eliminated. Using non-sterile medical pellets can lead to serious infections or other complications at the implantation site.
Who’s affected
Patients in Nevada who have been prescribed Testosterone 40 mg pellets by Partell Specialty Pharmacy. Individuals using the specific lot numbers listed below are at risk of infection due to potential lack of sterility.
How to tell if you have this one
Look for Testosterone 40 mg pellets packaged in an amber vial with 'Rx only' labeling from Partell Specialty Pharmacy, located at 5835 S. Eastern Ave. #101, Las Vegas, NV 89119. Affected lots are: 20171214@90 (BUD 06/12/2018), 20171113@81 (BUD 05/12/2018), and 20180220@58 (BUD 08/19/2018).
- Brand
Partell Specialty Pharmacy- Category
Drug
All 49 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
NV only
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0634-2018 | Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180201@34, BUD 04/02/2018; 20180202@56, BUD 04/03/2018; 20180129@41, BUD 3/30/2018; 20180207@16, BUD 04/08/2018. | 4 vials |
| D-0635-2018 | B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180205@18, BUD 04/06/2018; 20180126@28, BUD 03/27/2018; 20180126@22, BUD 03/27/2018; 20180205@9, BUD 04/06/2018; 20180214@17, BUD 04/14/2018. | 5 vials |
| D-0636-2018 | Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot #:20180216@10, BUD 5/17/2018; 20180129@25, BUD 04/29/2018. | 2 vials |
| D-0637-2018 | CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20171227@14, BUD 03/27/2018; 20180205@37, BUD 05/06/2018; 20180214@30, BUD 05/15/2018. | 3 vials |
| D-0638-2018 | Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180219@58, BUD 05/20/2018; 20180131@15, BUD 05/01/2018; 20180116@9, BUD 04/14/2018; 20180103@5, BUD 04/03/2018. | four vials |
| D-0639-2018 | HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; a) Lot#: 20180219@6, BUD 04/05/2018; b) 20180207@14, BUD 03/24/2018; 0180214@22, BUD 03/31/2018; 20180220@7, BUD 04/06/2018. | four vials |
| D-0640-2018 | Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180124@10, BUD 04/05/2018; 20180220@9, BUD 05/21/2018; 20180102@33, BUD 04/02/2018. | — |
| D-0641-2018 | Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; a) Lot #: 20180129@18, BUD 4/14/2018 b) Lot #: 20171127@6, 20180207@12, 20180108@16, BUD 04/14/2018. | 11 vials |
| D-0642-2018 | Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; a) Lot #: 20180123@9, 20171222@11, BUD 4/14/2018, 20180214@7, BUD 08/14/2018. b) Lot #: 20180221@3,BUD 08/21/2018, 20180214@6; BUD 08/14/2018. | — |
| D-0643-2018 | Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180221@15, BUD 05/22/2018, 20180123@10, BUD 04/23/2018. | 2 vials |
| D-0644-2018 | Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot #: 20180130@2, BUD 7/29/2018; 20180109@1, BUD 07/08/2018; 20180212@51, BUD 08/11/2018;, 20171212@4, BUD 06/10/2018; 20180123@6, BUD 07/22/2018; 20171204@4, BUD 06/02/2018; 20171228@15, BUD 03/28/2018. | 7 vials |
| D-0645-2018 | TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180212@22, BUD 03/29/2018; 20180226@64, BUD 04/02/2018. | 15 vials |
| D-0646-2018 | Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. # 101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180220@4, BUD 03/22/2018, 20180221@14, BUD 03/23/2018, 20180228@1, BUD 03/30/2018. | 4 vials |
| D-0647-2018 | Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot #: 20180123@4, BUD 4/14/2018. | 1 vial |
| D-0648-2018 | Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180219@90, BUD 08/18/2018 | — |
| D-0649-2018 | Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20171017@85, BUD: 04/15/2018 | one vial |
| D-0650-2018 | Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 twist top surrounded by a wrapper,; Lot#: 20171220@10, BUD 06/18/201; 20171017@83, BUD 04/15/2018; 20171102@40, BUD 05/01/2018; 20180118@97, BUD 07/17/2018; 00180213@32, BUD 08/12/2018. | five vials |
| D-0651-2018 | Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20171220@11, BUD 06/18/2018; 20180201@33, BUD 07/31/2018. | — |
| D-0652-2018 | Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride 80mg/8mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, twist top surrounded by a wrapper; Lot#: 20171010@76, BUD: 04/08/2018. | 1 vial |
| D-0653-2018 | Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20171012@63, BUD 04/10/2018, 20171127@103, BUD 05/26/2018, 20180115@69, BUD 07/14/2018. | 7 vials |
| D-0654-2018 | Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180111@104, BUD 07/10/2018. | one vial |
| D-0655-2018 | Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: a) 20180119@4, 20171016@10, 20171106@5, 20171214@55, 20180207@5 BUD 04/14/2018; 20180212@15, BUD 03/29/2018; 20180117@26, BUD 07/16/2018. b) 20180219@17, BUD 08/18/2018; 20180205@1, 20180102@39, 20180124@3, BUD 04/14/2018; 20180221@23, BUD 08/20/2018. | — |
| D-0656-2018 | MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1000 mg)/ vial liquid injectable, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot #: 20180223@1, BUD 04/24/2018; 20180129@5, BUD 03/30/2018; 20180126@4, BUD 03/27/2018; 20180215@22, BUD 04/16/2018; 20180122@10, 20180126@4, BUD 03/23/2018; 20180202@27, BUD 04/03/2018; 20180208@5, 20180201@2, BUD 04/02/2018; # 20180207@2, BUD 04/08/2018, 20180214@11, BUD 04/15/2018; 20180215@22, BUD 04/16/2018. | — |
| D-0657-2018 | Testosterone Propionate 100mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot #: 20171228@15, BUD 03/28/2018 | — |
| D-0658-2018 | TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180219@27, 20180212@18, BUD 04/02/2018. | — |
| D-0659-2018 | TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180206@7, BUD 03/23/2018, 20180212@41, BUD 03/29/2018, 20180219@40, BUD 04/02/2018. | — |
| D-0660-2018 | TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180219@31, BUD 04/02/2018; 20180212@42, 20180206@12, BUD 03/29/2018. | — |
| D-0661-2018 | TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180206@3, BUD 03/23/2018; 20180212@15, BUD 03/29/2018, 20180219@16, BUD 04/02/2018. | — |
| D-0662-2018 | Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3; Lot#: 20171128@9, BUD 05/27/2018; 20171201@74, BUD 05/30/2018; 20171211@68, BUD 06/09/2018; 20171218@51, BUD 06/16/2018; 20171222@6, BUD 06/20/2018; 20180209@62, BUD 08/08/2018; 20180223@46, BUD 08/22/2018; 20180223@33, BUD 08/22/2018; 20180219@5, BUD 08/18/2018; 20171010@11, BUD 04/08/2018; 20171019@19, BUD 04/17/2018; 20171031@69, BUD 04/29/2018; 20171102@27, BUD 05/01/2018; 20171110@87, BUD 05/09/2018; 20171114@12, BUD 05/13/2018; 20171122@57, BUD 05/21/2018; 20180112@56, BUD 07/11/2018; 20180116@77, BUD 07/15/2018; 20180122@92, BUD 07/21/2018; 20180202@69, BUD 08/01/2018; 20180205@111, BUD 08/04/2018; 20180212@102, BUD 08/11/2018. | — |
| D-0663-2018 | Testosterone 100 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20171212@17, BUD 06/10/2018; 20180205@40, BUD 08/04/2018; 20180208@42, BUD 08/07/2018; 20170929@42, BUD 03/28/2018; 20171013@33, BUD 04/11/2018; 20171020@25, BUD 04/18/2018; 20171025@52, BUD 04/23/2018; 20171101@70, BUD 04/30/2018; 20171106@31, BUD 05/05/2018; 20171116@17, BUD: 05/15/2018, 20171116@42, BUD 05/15/2018; 20180117@87, BUD: 07/16/2018; 20180201@76, BUD 07/31/2018; 20180220@67, BUD 08/19/2018; 20180202@67, BUD 08/01/2018. | — |
| D-0664-2018 | Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180130@61, BUD 07/29/2018; 20180208@17, BUD 08/07/2018, 20170928@27, BUD 03/27/2018; 20171025@49, BUD 04/23/2018; 20171109@42, BUD 05/08/2018; 20171117@1, BUD 05/16/2018; 20180130@96, BUD 07/29/2018. | — |
| D-0665-2018 | Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20180220@87, BUD 08/19/2018; 20171113@80, BUD 05/12/2018. | — |
| D-0666-2018 | Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20171214@90, BUD 06/12/2018; 20171113@81, BUD 05/12/2018; 20180220@58, BUD 08/19/2018. | — |
| D-0667-2018 | Testosterone 50 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#:0180126@48, BUD 07/25/2018; 20171109@48, BUD 05/08/2018 | — |
| D-0668-2018 | Testosterone 55 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20171024@53, BUD 04/22/2018; 20180219@91, BUD 08/18/2018. | — |
| D-0669-2018 | Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800; Lot#: 20171213@93, BUD 06/11/2018; 20171220@78, BUD 06/18/2018; 20171017@41, BUD 04/15/2018; 20171117@2, BUD 05/16/2018; 20171213@93, BUD 06/11/2018. | — |
| D-0670-2018 | Testosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20171116@3, BUD 05/15/2018; 20180221@72, BUD, 08/20/2018; 20171130@79, BUD 05/29/2018; 20180221@72, BUD 08/20/2018; 20180206@115, BUD 08/05/2018; 20171023@98, BUD 04/21/2018. | — |
| D-0671-2018 | Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20171130@64, BUD 05/29/2018. | — |
| D-0672-2018 | Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20171122@65, BUD 05/21/2018; 20171115@56, BUD 05/14/2018; 20171002@77, BUD 03/31/2018; 20171006@63, BUD 04/04/2018; 20171009@55, BUD 04/07/2018; 20171117@72, BUD 05/16/2018. | — |
| D-0673-2018 | Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20171201@84, BUD: 05/30/2018; 20180125@31, BUD 07/24/2018; 20180209@106, BUD 08/08/2018; 20171011@69, BUD 04/09/2018; 20171019@10, BUD 04/17/2018; 20171106@103, BUD 05/05/2018. | — |
| D-0674-2018 | Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; a) Lot#: 20180219@88, 20180208@19, 20180219@45, BUD 08/18/2018. | — |
| D-0675-2018 | Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20171204@117, BUD 06/02/2018; 20180129@14, BUD 07/28/2018; 20171011@111, BUD 04/09/2018. | — |
| D-0676-2018 | Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20180129@15, BUD 07/28/2018; 20171207@83, BUD 06/05/2018; 20171016@27, BUD 04/14/2018; 20171204@15, BUD 06/02/2018; 20171006@57, BUD 04/04/2018; 20171018@62, BUD 04/16/2018; 20180116@24, BUD 07/15/2018. | — |
| D-0677-2018 | Estradiol 25 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20171204@15, BUD 06/02/2018; 20171006@57, BUD 04/04/2018; 20171018@62, BUD 04/16/2018; 20180116@24, BUD 07/15/2018. | — |
| D-0678-2018 | Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot: #20171102@42, BUD 05/01/2018. | — |
| D-0679-2018 | Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20171017@87, BUD 04/15/2018. | — |
| D-0680-2018 | Estradiol 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20171009@49, BUD 04/07/2018. | — |
| D-0681-2018 | Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; Lot#: 20180104@73, BUD 07/03/2018. | — |
| D-0682-2018 | Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.; 20180110@57, 20180110@23 BUD 07/09/2018, 20171003@91, BUD 04/01/2018, 20171016@24, BUD 04/14/2018. | — |
What to do — step by step
Stop Using the Product
Do not use any Testosterone 40 mg pellets from the affected lots due to the risk of non-sterility.
Contact Your Provider
Consult your healthcare provider immediately regarding alternative treatments or further instructions for the recalled product.
Where it went and when
Where it was distributed
Distributed in Nevada.
FDA distribution: “NV only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Nevada.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0666-2018 (March 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0666-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- 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.