KRS Global Recalls Human Chorionic Gonadotropin Tablets Due to Labeling Error
KRS Global Biotechnology is recalling 2,239 Human Chorionic Gonadotropin tablets because the expiration date exceeds the shelf life of an ingredient.
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 2/5 (Moderate).
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 due to a labeling error regarding expiration dates, which fits the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 2,239 tablets of Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT). The recall is due to a labeling error where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.
The affected product is prescription-only and was distributed nationwide in the USA, Bermuda, and New Zealand. The specific lot number is 06132017@22, and the Beyond Use Date is listed as 12/10/2017.
Consumers and healthcare providers should check their inventory for this specific lot and discontinue use if found. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,239
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)
- Lot: 06132017@22 BUD: 12/10/2017
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 →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- SevereKRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereSynergy Rx Recalls Human Chorionic Gonadotropin Tablets Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- CriticalComplete Pharmacy Recalls Non-Sterile Human Chorionic Gonadotropin Vials
FDA (Drugs) · 2017-06-21
- SevereFDA Recalls Chorionic Gonadotropin Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
- SeverePharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns
FDA (Drugs) · 2019-06-19
- SevereKRS Global Biotechnology Recalls Quadmix # 19 Due to Sterility Concerns
FDA (Drugs) · 2019-10-09