US Drug Recall Register
Class III · Low risk Terminated Initiated Apr 17, 2014 (12 years ago)

Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

What was recalled

Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .

Recalling firm
Wockhardt Usa Inc.
NDC code
64679-735-02
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0304-2015

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.

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