FDA Recalls Ketamine Syringes Due to Lack of Sterility Assurance
KRS Global Biotechnology is recalling 1,044 syringes of Ketamine in 0.9% Sodium Chloride because the product lacks assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classifies this as a Class II recall. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug is a significant hazard that fits the Severe criteria for Class II drug recalls.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe. The product is manufactured by KRS Global Biotechnology, Inc. and is identified by NDC 33216077967. The recall involves 1,044 syringes distributed nationwide.
The reason for the recall is a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microorganisms, which poses a risk of infection if administered. The recall covers all lots of the product that remain within their expiration dates.
Healthcare providers and patients who have this product should stop using it immediately. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216077967
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,044
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 · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15