Class II · Moderate risk Ongoing
Divalproex Sodium Delayed-Release Tablets
Reason Presence of Foreign Tablets/Capsules
Divalproex Sodium Delayed-release Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsule Specifications
What was recalled
Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
- Recalling firm
- Teva North America
- NDC code
- 0093-7440-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1449-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Divalproex recalls
See all
Class II · Moderate risk Terminated
Divalproex Sodium Extended-release Tablets
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Divalproex Sodium Extended Release Tablets
Reason Failed dissolution specifications.
Class II · Moderate risk Terminated
Divalproex Sodium Delayed-Release Tablets
Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets
Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
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