CLASS II Drug recall · Reported 3 Apr 2024 · FDA Enforcement Report
Divalproex Sodium Extended-release Tablets, USP 250 mg recalled
Amneal Pharmaceuticals of New York is recalling Divalproex Sodium Extended-release Tablets, USP 250 mg, distributed nationwide in the US. The recall was initiated on 26 Dec 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-0426-2024
- FDA event ID
- 93976
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Brand
- Divalproex Sodium
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Dec 2023
- FDA classified
- 27 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 26 Dec 2023 | Recall initiated by company | |
| 27 Mar 2024 | Classified by FDA | +92 days |
| 3 Apr 2024 | 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 dissolution specifications
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
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
Where it was distributed
Product was distributed nationwide.
Questions about this recall
Why was it recalled?
Failed dissolution specifications
Which lots are affected?
Lot # AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024
Where was it sold?
Product was distributed 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.
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 | 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 |
| Drug | CLASS II | Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
Other Divalproex recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalledDivalproex Sodium | Bionpharma | Other | 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 | Divalproex Sodium Delayed-Release Tablets, USP 500mg recalledDivalproex Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP Tablets recalledDivalproex Sodium | Major Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) bottle recalled | Dr. Reddy's Laboratories | Manufacturing (CGMP) Deviations | Nationwide |