Labetalol HCl syringes are recalled due to lack of sterility assurance
The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes because there was insufficient assurance of sterility during production. No illnesses or injuries have been reported.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves a drug (Labetalol HCl) with no reported illnesses or injuries, and the hazard (lack of sterility assurance) is theoretical rather than confirmed contamination. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3, making this a Low severity recall.
Plain-English summary
The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes manufactured by KRS Global Biotechnology, Inc. The recall is initiated due to a lack of assurance of sterility, indicating potential contamination risks that were not detected during testing.
All syringes containing Labetalol HCl 5 mg/mL (20 mg/4 mL) distributed nationwide are affected. Consumers who have received these syringes should dispose of them immediately and contact their healthcare provider. The manufacturer, KRS Global Biotechnology, Inc., is responsible for addressing this recall and providing further guidance.
This recall does not involve confirmed cases of illness or injury. The FDA is taking action to ensure patient safety by removing potentially non-sterile products from the market.
The recalled product
- Product
- Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 6,405
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.
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