Fresenius Kabi Recalls Folic Acid Injection Due to Impurities
Fresenius Kabi USA is recalling 80,480 vials of Folic Acid Injection due to failed impurities and degradation specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 80,480 vials of Folic Acid Injection, USP, 5 mg/mL. The product is a 10 mL multiple-dose vial intended for intramuscular, intravenous, or subcutaneous use. The recall is being conducted because the product failed impurities and degradation specifications.
The affected product is identified by Lot # 6103883 with an expiration date of 10/2013. The NDC number is 63323-184-11. The product was distributed nationwide and in Puerto Rico.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Healthcare providers and patients should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 80,480
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 (2)
- Lot #: 6103883
- Exp 10/2013
Distribution
Related recalls
Same manufacturer · Fresenius Kabi USA, LLC
See all →- SevereFresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
- CriticalFresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
- HighXylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateFDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08