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
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDC
0904-6363-61
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 00904-6363 |
250 mg/1 | Tablet, Film Coated, Extended Release Oral |
Major Pharmaceuticals | Rx |
- Recalling firm
- Major Pharmaceuticals
- NDC code
- 0904-6363-61
- Origin
- MI, United States
- Initiated by
- N/A
- FDA recall number
- D-1583-2019 · 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 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.
Other recalls by Major Pharmaceuticals
All 2019 recalls
Class II · Moderate risk
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Class II · Moderate risk
Levothyroxine Sodium Tablets
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Class II · Moderate risk
Levothyroxine Sodium Tablets
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Class II · Moderate risk
Levothyroxine Sodium Tablets
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