Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
FOLIC ACID INJECTION Recalled by Fresenius Kabi USA, LLC Due to Failed Impurities/Degradation specifications: out-of-specification results 14 & 15...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA, LLC directly.
Affected Products
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11
Quantity: 215,340 vials
Why Was This Recalled?
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report