Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Presence of Foreign Tablets/Capsules
Divalproex Sodium Extended Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Affected NDC
65162-0755-10
Compare with the code on your package — it is the most precise check available.
Drug: Divalproex
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Divalproex Sodium NDC 65162-0755 |
250 mg/1 | Tablet, Extended Release Oral |
Amneal Pharmaceuticals LLC | Rx |
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- NDC code
- 65162-755-10
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1362-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Divalproex recalls
See all
Class II · Moderate risk
Divalproex Sodium Extended-release Tablets
Failed dissolution specifications
Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Other recalls by Amneal Pharmaceuticals of New York, LLC
All 2022 recalls
Class II · Moderate risk
Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
Class II · Moderate risk
Methylergonovine Maleate Tablets
Failed Dissolution Specifications
Class I · High risk
Vancomycin Hydrochloride for Oral Solution
Superpotent Drug: Due to overfilling of drug powder
Class II · Moderate risk
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Failed Impurities/Degradation Specifications: Out-of-specification test results.
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