CLASS II Drug recall · Reported 21 Jun 2023 · FDA Enforcement Report
Extended Phenytoin Sodium Capsules, USP, 100 mg recalled
Amneal Pharmaceuticals of New York is recalling Extended Phenytoin Sodium Capsules, USP, 100 mg, distributed in Louisiana, Ohio, Pennsylvania. The recall was initiated on 30 May 2023 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-0876-2023
- FDA event ID
- 92368
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 May 2023
- FDA classified
- 15 Jun 2023
- Reported
- 21 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 30 May 2023 | Recall initiated by company | |
| 15 Jun 2023 | Classified by FDA | +16 days |
| 21 Jun 2023 | 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
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
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
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Where it was distributed
LA, PA and OH.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Which lots are affected?
Lot # HL00721A, Exp. 12/2023
Where was it sold?
LA, PA and OH.
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.
More recalls from Amneal Pharmaceuticals of New York
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
Other Phenytoin recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Phenytoin Oral Suspension, USP, 100 mg recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS III | Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium | Acella Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Phenytoin Sodium Injection, USP, 250 mg recalledPhenytoin Sodium | Acella Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS I | Phenytoin Oral Suspension USP, 125 mg/ potency recalledPhenytoin | Taro Pharmaceuticals U | Potency & Assay | Nationwide |