CLASS II Drug recall · Reported 16 Jul 2014 · FDA Enforcement Report
Fosphenytoin Sodium Injection, USP, 500 mg PE recalled
Fresenius Kabi USA is recalling Fosphenytoin Sodium Injection, USP, 500 mg PE/ (50 mg PE/mL), (PE= phenytoin sodium, distributed nationwide in the US. The recall was initiated on 2 May 2014 and the FDA has classified it as Class II.
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-1429-2014
- FDA event ID
- 68152
- Recalling firm
- Fresenius Kabi USA, Melrose Park, IL
- Brand
- Fosphenytoin
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2014
- FDA classified
- 9 Jul 2014
- Reported
- 16 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 2 May 2014 | Recall initiated by company | |
| 9 Jul 2014 | Classified by FDA | +68 days |
| 16 Jul 2014 | 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
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Product as listed by the FDA
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Which lots are affected?
Lot # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005973; 04/15 6005974; 04/15 6006035; 05/15 6006036; 05/15 6006037; 05/15 6006174; 05/15 6006175; 05/15 6006176; 06/15 6006449; 07/15 6006450; 07/15 6006451; 07/15 6007168; 11/15
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
1 other product · FDA event 68152This product is part of a recall event; the main page for the event is Fosphenytoin Sodium Injection, USP, 100 mg PE recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin | Fresenius Kabi USA | Particulate Matter | Nationwide |
More recalls from Fresenius Kabi USA
All 94| 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 Fosphenytoin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fosphenytoin Sodium Injection, USP 500 mg PE* recalled | Amneal Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Fosphenytoin Sodium Injection, USP, 500 mg PE recalled | Amneal Pharmaceuticals | Particulate Matter | 5 states |
| Drug | CLASS II | Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin Sodium | West-ward Pharmaceutical | Particulate Matter | Nationwide |
| Drug | CLASS II | Fosphenytoin Sodium Injection, USP, 500 mg PE recalledFosphenytoin Sodium | West-ward Pharmaceutical | Particulate Matter | Nationwide |