KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,263 vials of Human Chorionic Gonadotropin 6,000 Units due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 2,263 vials of Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use. The product is identified by NDC 3321673969 and is distributed nationwide. The recall includes all lots remaining within their expiry dates.
The recall was initiated because of a lack of assurance of sterility. This is a prescription-only medication intended for subcutaneous or intramuscular use.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Medication
- Affected units
- 2,263
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by KRS Global Biotechnology, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 80 products in this recall →Related recalls
Same manufacturer · KRS Global Biotechnology, Inc
See all →- SevereKRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereKRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereFDA Recalls Phenylephrine IV Bags Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- ModerateSermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereKRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
Same hazard · sterility
See all →- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- SevereSterling Recalls Carboxymethylcellulose Sodium Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereSterling Pharmaceutical Recalls Lubricating Tears Due to Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereWalgreens Lubricant Eye Drops Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2026-09-30
- SevereSodium Chloride Ophthalmic Solution Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
Similar recalls
- ModerateKRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Recalls Human Chorionic Gonadotropin Tablets Due to Labeling Error
FDA (Drugs) · 2018-01-17
- SevereSynergy Rx Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- SeverePharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
FDA (Drugs) · 2018-09-05
- SeverePharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns
FDA (Drugs) · 2019-06-19