Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failure
Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed long-term stability testing for dissolution specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a violation of labeling or the FD&C Act that is not likely to cause adverse health consequences. The hazard is a stability/dissolution failure without reported injuries.
Plain-English summary
Wockhardt USA is recalling specific lots of Metoprolol Succinate, Extended-Release Tablets USP, 50 mg. The affected products are distributed in 100-count HDPE bottles (NDC 64679-735-02) and 4000-count packs (NDC 64679-735-08). The recall covers approximately 1,118,400 extended-release tablets distributed nationwide.
The recall was initiated because the product was found to be out of specification (OOS) at the 12-month long-term stability testing point regarding dissolution specifications. This means the tablets may not dissolve at the required rate over time, potentially affecting the delivery of the medication.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. Affected lots include Lot # LN10392 and Lot # LN10360, both with an expiration date of 12/14. Patients should contact their healthcare provider or pharmacist for guidance on alternative medications or further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Wockhardt Usa Inc.
- Category
- Drug — Cardiovascular
- Affected units
- 1,118,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- a) Lot # LN10392
- Exp. 12/14 b) Lot # LN10360
- Exp. 12/14
Distribution
Distributed nationwide across the United States.
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