Fresenius Kabi USA, LLC is recalling 215,340 vials of Folic Acid Injection, USP (5 mg/mL) sold in 10 mL multiple-dose vials. The recall was initiated because stability testing for two lots showed levels of impurities that exceeded approved specifications, and a third lot is expected to develop the same issue before its expiration date. This medication is used for both human and veterinary purposes (under the APP Pharmaceuticals brand) to treat folic acid deficiency.
The presence of impurities above the approved limit can reduce the effectiveness of the medication or potentially cause unexpected side effects. While the risk is considered low, using a product that does not meet stability standards may not provide the intended therapeutic benefit to the patient.
Refund or replacement for out-of-specification medication
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response