Unrated Drug recall · FDA · Published November 16, 2017
KRS Global Biotech Recalls HCG Vials Due to Labeling Errors
KRS Global Biotechnology recalls Human Chorionic Gonadotropin vials because labeling may show an incorrect Beyond Use Date exceeding ingredient expiration.
Recall notice
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Contact the company
Recalling firmKRS Global Biotechnology, Inc791 Park of Commerce Blvd Ste 600 · Boca Raton, FL 33487-3633
What happened, in plain English
KRS Global Biotechnology, Inc. is recalling Human Chorionic Gonadotropin 6,000 iu/Vial (For SC Use -Lyophilized) due to a labeling error. The recall affects Lot 08302017@11, which has a Beyond Use Date of 2/26/2018. The hazard is that this date may exceed the expiration of at least one ingredient used to make the final product. The record does not specify a remedy or action for consumers. Read more at govinfonow.com/recall/41049-krs-global-biotech-recalls-hcg-vials-due-to-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/41049-krs-global-biotech-recalls-hcg-vials-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0176-2018
Cite this page
“KRS Global Biotech Recalls HCG Vials Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41049-krs-global-biotech-recalls-hcg-vials-due-to-labeling-errors. Based on FDA recall #D-0176-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0176-2018%22&limit=1).
Why it’s dangerous
The labeling indicates a Beyond Use Date (BUD) of 2/26/2018 for Lot 08302017@11. This date may exceed the expiration date of at least one ingredient used to manufacture the final product, potentially compromising the drug's stability or efficacy.
Who’s affected
Individuals who purchased or were prescribed Human Chorionic Gonadotropin 6,000 iu/Vial from KRS Global Biotechnology between the manufacturing date and November 16, 2017. The product was distributed nationwide in the USA, Bermuda, and New Zealand.
How to tell if you have this one
Check your vial for the brand KRS Global Biotechnology and the specific Lot number 08302017@11. Verify if the Beyond Use Date is listed as 2/26/2018. The product is Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only.
- Brand
KRS Global Biotechnology- Category
Drug
All 47 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 in the USA, Bermuda, and New Zealand
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0161-2018 | Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 03092017@21 BUD: 3/9/2018; 03292017@33 BUD: 3/24/2018; 05092017@38 BUD: 5/4/2018; 05162017@31 BUD: 5/11/2018; 05182017@25 BUD: 5/13/2018; 07032017@40 BUD: 6/28/2018; 07142017@34 BUD: 7/9/2018; 07192017@32 BUD: 7/14/2018; 08282017@25 BUD: 8/23/2018; 09142017@8BUD: 9/9/2018; 09212017@23 BUD: 9/16/2018; 09272017@36 BUD: 9/ 22/2018; 10162017@39 BUD: 10/11/2018; 11032017@28 BUD: 10/29/2018 | 15,700 capsules |
| D-0162-2018 | Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 07282017@25 BUD: 1/24/2018 | 80 vials |
| D-0163-2018 | Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 02022017@30 BUD: 1/28/2018; 04172017@29 BUD: 4/12/2018; 05082017@39 BUD: 5/3/2018; 05222017@23 BUD: 5/17/2018; 06072017@28 BUD: 6/2/2018; 06122017@42 BUD: 6/7/2018; 06192017@24 BUD: 6/14/2018; 06292017@25 BUD: 6/24/2018; 07112017@33 BUD: 7/6/2018; 07172017@35 BUD: 7/12/2018; 07282017@26 BUD: 7/23/2018; 08012017@25 BUD: 7/27/2018; 08112017@35 BUD: 8/9/2018; 08142017@30 BUD: 8/9/2018; 08172017@31 BUD: 8/12/2018; 09202017@21 BUD: 9/15/2018; 09142017@27 BUD: 9/9/2018; 10022017@38 BUD: 3/31/2018; 10102017@37 BUD: 4/8/2018; 10172017@26 BUD: 4/15/2018; 10202017@22 BUD: 4/18/2018; 10302017@29 BUD: 4/28/2018 | 22,520 capsules |
| D-0164-2018 | Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.; Lot: 05242017@54 BUD: 11/20/2017 | 490 jars |
| D-0165-2018 | Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 06072017@22 BUD: 12/4/2017; 06222017@30 BUD: 12/19/2017; 08032017@31 BUD: 1/30/2018; 09212017@21 BUD: 3/20/2018; 10232017@20 BUD: 11/22/2017 | 4,530 jars |
| D-0166-2018 | Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 07142017@31 BUD: 1/10/2018; 09202017@22 BUD: 3/19/2018; 10042017@25 BUD: 4/2/2018 | 1,380 jars |
| D-0167-2018 | Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 06072017@38 BUD: 12/4/2017; 07062017@48 BUD: 1/2/2018; 08012017@23 BUD: 1/28/2018; 08212017@36 BUD: 2/17/2018; 09182017@26 BUD: 3/17/2018 | 3,280 jars |
| D-0168-2018 | Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.; Lot: 08172017@39 BUD: 12/15/2017 | 300 jars |
| D-0169-2018 | Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 08212017@24 BUD: 2/17/2018 | 90 capsules |
| D-0170-2018 | Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 08162017@32 BUD: 2/12/2018 | 20 jars |
| D-0171-2018 | Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 07282017@24 BUD: 1/24/2018; 08162017@33 BUD: 2/12/2018 | 100 jars |
| D-0172-2018 | Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 07182017@45 BUD: 1/14/2018 | 300 jars |
| D-0173-2018 | Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 06132017@22 BUD: 12/10/2017 | 2,239 tablets |
| D-0174-2018 | Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 06212017@19 BUD: 12/18/2017; 10052017@1 BUD: 4/3/2018 | 1,203 vials |
| D-0175-2018 | Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 06132017@2 BUD: 12/10/2017; 07262017@17 BUD: 1/22/2018; 10032017@1 BUD: 4/1/2018 | 6,414 vials |
| D-0176-2018 | Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 08302017@11 BUD: 2/26/2018 | 2,239 vials |
| D-0177-2018 | Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 06222017@10 BUD: 12/19/2017; 09272017@14 BUD: 3/26/2018; 05312017@5 BUD: 11/27/2017; 07192017@8 BUD: 1/15/2018 | 7,862 vials |
| D-0178-2018 | Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 06082017@33 BUD: 12/5/2017; 06152017@4 BUD: 12/12/2017; 07272017@4 BUD: 1/23/2018; 10042017@22 BUD: 4/2/2018; 09282017@3 BUD: 3/27/2018 | 2,274 vials |
| D-0179-2018 | Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 08222017@37 BUD: 11/20/2017 | 30 jars |
| D-0180-2018 | Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 10102017@9 BUD: 2/7/2018 | 1,009 vials |
| D-0181-2018 | Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 10162017@20 BUD: 2/13/2018 | 596 vials |
| D-0182-2018 | Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 07282017@23 BUD: 1/24/2018 | 40 jars |
| D-0183-2018 | Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.; Lots: 05022017@24 BUD: 4/27/2018; 10122017@21 BUD: 4/10/2018; 11062017@38 BUD: 5/5/2018; 08252017@28 BUD: 8/20/2018 | 970 capsules |
| D-0184-2018 | Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 09252017@7 BUD: 12/24/2017 | 696 vials |
| D-0185-2018 | Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 06062017@3 BUD: 12/3/2017 | 2,535 vials |
| D-0186-2018 | Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 10112017@10 BUD: 1/9/2018; 10252017@9 BUD: 1/23/2018 | 963 bags |
| D-0187-2018 | PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 07172017@40 BUD: 1/13/2018 | 3,000 tablets |
| D-0188-2018 | Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 09212017@22 BUD: 3/20/2018 | 300 jars |
| D-0189-2018 | QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 05242017@25 BUD: 11/20/2017 | 126 vials |
| D-0190-2018 | QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 05242017@27 BUD: 11/20/2017 | 122 vials |
| D-0191-2018 | QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 05242017@29 BUD: 11/20/2017 | 129 vials |
| D-0192-2018 | Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 06262017@31 BUD: 6/26/2018 | 30 droptainers |
| D-0193-2018 | Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 07112017@32 BUD: 1/7/2018 | 3,000 tablets |
| D-0194-2018 | Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 10122017@8 BUD: 2/9/2018 | 80 cartridges |
| D-0195-2018 | Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 06162017@12 BUD: 12/13/2017; 08042017@1 BUD: 1/31/2018 | 597 vials |
| D-0196-2018 | Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 06272017@4 BUD: 12/24/2017 | 157 vials |
| D-0197-2018 | Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 07052017@2 BUD: 1/1/2018 | 898 vials |
| D-0198-2018 | Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 05262017@21 BUD: 11/22/2017; 07132017@2 BUD: 1/9/2018 | 235 vials |
| D-0199-2018 | Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 06142017@6 BUD: 12/11/2017 | 94 vials |
| D-0200-2018 | T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 07122017@2 BUD: 1/8/2018 | 173 vials |
| D-0201-2018 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 09192017@20 BUD: 12/18/2017 | 297 droptainers |
| D-0202-2018 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 10042017@34 BUD: 1/2/2018 | 81 droptainers |
| D-0203-2018 | Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 07102017@4 BUD: 1/6/2018 | 479 vials |
| D-0204-2018 | Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots: 06092017@2 BUD: 12/6/2017; 07212017@16 BUD: 1/17/2018; 07312017@26 BUD: 1/27/2018; 08182017@5 BUD: 2/14/2018; 09222017@2 BUD: 3/21/2018; 09292017@2 BUD: 3/28/2018; 10062017@2 BUD: 4/4/2018 | 3612 vials |
| D-0205-2018 | Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lots; 05232017@13 BUD: 11/19/2017; 05262017@2 BUD: 11/22/2017; 06022017@1 BUD: 11/29/2017; 06092017@1 BUD: 12/6/2017; 06162017@10 BUD: 12/13/2017; 08142017@10 BUD: 2/10/2018; 08252017@1 BUD: 2/21/2018; 09222017@1 BUD: 3/21/2018; 09292017@1 BUD: 3/28/2018; 10062017@1 BUD: 4/4/2018; 10132017@2 BUD: 4/11/2018 | 5786 vials |
| D-0206-2018 | 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 08012017@35 BUD: 1/28/2018 | 90 capsules |
| D-0207-2018 | 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.; Lot: 06082017@36 BUD: 12/5/2017 | 90 capsules |
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide in the USA, Bermuda, and New Zealand” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.5 years 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.
Similar recalls
Latest drug recalls
Keep exploring
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-0176-2018 (November 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0176-2018 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.