CLASS II Drug recall · Reported 4 Apr 2018 · FDA Enforcement Report
Fosphenytoin Sodium Injection, USP 500 mg PE* recalled
Amneal Pharmaceuticals is recalling Fosphenytoin Sodium Injection, USP 500 mg PE*, distributed nationwide in the US. The recall was initiated on 15 Dec 2017 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-0610-2018
- FDA event ID
- 79610
- Recalling firm
- Amneal Pharmaceuticals, Brookhaven, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Dec 2017
- FDA classified
- 29 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Dec 2017 | Recall initiated by company | |
| 29 Mar 2018 | Classified by FDA | +104 days |
| 4 Apr 2018 | Published in enforcement report | +6 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 particulate matter
Product as listed by the FDA
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
Where it was distributed
U.S.A Nationwide
Questions about this recall
Why was it recalled?
Presence of particulate matter
Which lots are affected?
Lot #: AP160022, AP160023, Exp. 05/2018; AP16038, AP160039, AP160040, Exp. 06/2018; AP160076, AP160077, AP160078, Exp. 12/2018
Where was it sold?
U.S.A Nationwide
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.
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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 | 5 states |
| Drug | CLASS II | Fosphenytoin Sodium Injection, USP, 500 mg PE recalledFosphenytoin | Fresenius Kabi USA | Particulate Matter | Nationwide |
| 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 |