KRS Global Biotechnology Recalls L-Carnitine Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling L-Carnitine vials nationwide because the company cannot ensure the product is sterile.
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 and involves a lack of assurance of sterility, which poses a risk of serious injury or death, meeting the criteria for a Severe rating.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling L-Carnitine 27 mL in a 30 mL Vial (NDC 3321674166). The recall involves 10,014 vials distributed nationwide. The specific reason for the recall is a lack of assurance of sterility.
The affected product is a prescription-only medication. All lots remaining within their expiry date are included in this recall. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected L-Carnitine vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Medication
- Affected units
- 10,014
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
- SevereWells Pharmacy Recalls Carnitine-L Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereGreen Valley Drugs Recalls L-Carnitine Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- SevereTri-Coast Pharmacy Recalls L-Carnitine Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereMedaus Recalls L-Carnitine Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- HighL-Carnitine Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-09-21
- SevereMedaus Recalls L-Carnitine Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-07-20