KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors
KRS Global Biotechnology is recalling 1,203 vials of Human Chorionic Gonadotropin due to incorrect or missing lot and expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding expiration dates, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 1,203 vials of Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only. The recall was initiated because the products have incorrect or missing lot and/or expiration dates. Specifically, the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.
The affected lots are 06212017@19 with a BUD of 12/18/2017, and 10052017@1 with a BUD of 4/3/2018. These products were distributed nationwide in the USA, Bermuda, and New Zealand.
Consumers and healthcare providers should stop using the affected vials and contact KRS Global Biotechnology for further instructions or a return.
The recalled product
- Product
- 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.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Biologic
- Hazard
- Affected units
- 1,203
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 (2)
- Lots: 06212017@19 BUD: 12/18/2017
- 10052017@1 BUD: 4/3/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 47 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 47 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 · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02