CLASS III Drug recall · Reported 25 Dec 2013 · FDA Enforcement Report
Folic Acid Injection recalled by Fresenius Kabi USA
Fresenius Kabi USA is recalling Folic Acid Injection, USP, distributed nationwide in the US. The recall was initiated on 6 Dec 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-379-2014
- FDA event ID
- 67054
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Dec 2013
- FDA classified
- 18 Dec 2013
- Reported
- 25 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Dec 2013 | Recall initiated by company | |
| 18 Dec 2013 | Classified by FDA | +12 days |
| 25 Dec 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide, Puerto Rico, Canada, New Zealand
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Which lots are affected?
Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
Where was it sold?
Nationwide, Puerto Rico, Canada, New Zealand
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Folic Acid recalls
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Folic Acid Tablets, USP, 1MG recalled by Cardinal HealthcareFolic Acid | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Folic Acid 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose vial recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Folic Acid 10mg/ML Mdv Inj recalled by First Royal Care Co. LLC | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Folic Acid 5MG/ML Injection Solution (Mdv) per vial recalled | RXQ Compounding | Sterility | Nationwide |