US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 19, 2017 (9 years ago)

Divalproex Sodium Delayed Release Tablets USP

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.

What was recalled

Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01

Recalling firm
Unichem Pharmaceuticals Usa Inc
NDC code
29300-140-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0228-2018

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 Delayed-Release Tablets

Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

Sun Pharmaceutical Industries INC NDC 62756-798-88 D-1291-2022
Class II · Moderate risk Terminated

Divalproex Sodium Extended-Release Tablets

Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Major Pharmaceuticals NDC 0904-6363-61 D-1583-2019