KRS Global Biotechnology Recalls Vitamin D Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 508 vials of Vitamin 10 D Lyophilized due to a lack of assurance of sterility. The product is distributed nationwide.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury (such as sterility issues in injectable drugs) are rated as Severe.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 508 vials of Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use. The recall is being conducted because of a lack of assurance of sterility. The product is prescription-only and is identified by NDC 3321678341.
The recall covers all lots remaining within their expiry date. The product was distributed nationwide. No specific lot numbers or expiration dates are provided in the source text.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Vitamin
- Affected units
- 508
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 →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- ModerateKRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls Vitamin 9 Vials Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls Vitamin 9 A/B Lyophilized Vials Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls Sincalide Vials Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- SeverePromise Pharmacy Recalls Vitamin D3 Injections Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- SeverePartell Specialty Pharmacy Recalls Vitamin D Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-04-25