CLASS II Drug recall · Reported 7 Aug 2019 · FDA Enforcement Report
Divalproex Sodium Extended-release Tablets, USP Tablets recalled
Major Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets, USP Tablets, 250 mg-unit dose, distributed nationwide in the US. The recall was initiated on 24 Apr 2019 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-1583-2019
- FDA event ID
- 83460
- Recalling firm
- Major Pharmaceuticals, Livonia, MI
- Brand
- Divalproex Sodium
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2019
- FDA classified
- 1 Aug 2019
- Reported
- 7 Aug 2019
- Type
- N/A
- Customers notified by
- N/A
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Seizure Medication
Timeline
| 24 Apr 2019 | Recall initiated by company | |
| 1 Aug 2019 | Classified by FDA | +99 days |
| 7 Aug 2019 | 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
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Product as listed by the FDA
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Which lots are affected?
Lot# M02250 EXP 10/2020.
Where was it sold?
Nationwide in the USA
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 Major Pharmaceuticals
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 50 mcg recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 25 mcg recalledLevothyroxine Sodium | Major Pharmaceuticals | 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 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, 250 mg a) bottle recalled | Dr. Reddy's Laboratories | Manufacturing (CGMP) Deviations | Nationwide |