CLASS II Drug recall · Reported 24 Apr 2019 · FDA Enforcement Report
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) bottle recalled
Dr. Reddy's Laboratories is recalling Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) bottle (, distributed nationwide in the US. The recall was initiated on 11 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-1133-2019
- FDA event ID
- 82617
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Apr 2019
- FDA classified
- 15 Apr 2019
- Reported
- 24 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Seizure Medication
Timeline
| 11 Apr 2019 | Recall initiated by company | |
| 15 Apr 2019 | Classified by FDA | +4 days |
| 24 Apr 2019 | Published in enforcement report | +9 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, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Where it was distributed
Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
Questions about this recall
Is Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) bottle ( recalled?
Yes. Dr. Reddy's Laboratories recalled Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) bottle ( on 11 Apr 2019. The recall is Class II and its status is Terminated. Recall number D-1133-2019.
Why was it recalled?
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Which lots are affected?
Lot #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020
Where was it sold?
Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
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 21 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 Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | 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 Tablets recalledDivalproex Sodium | Major Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |