Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failure
Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution testing at the nine-month time point.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a contamination or mislabeling of a common allergen, fitting the Moderate severity criteria.
Plain-English summary
Wockhardt USA Inc. is recalling 109,744 bottles of Metoprolol Succinate Extended-Release Tablets, USP, 50 mg. The product is distributed nationwide and is available by prescription only. The specific lots affected are LN10686, LN10687, LN10688, LN10707, and LN10708, all with an expiration date of 02/15.
The recall was initiated because the tablets failed to meet dissolution specifications. Specifically, a failure of the dissolution test was observed at the nine-month time point. This means the tablets may not release the medication into the body as intended over time.
Patients who have been prescribed this medication should contact their healthcare provider or pharmacist for guidance on alternative treatments or replacement prescriptions. Consumers should not attempt to alter the medication or continue using it without professional advice.
The recalled product
- Product
- Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
- Manufacturer
- Wockhardt Usa Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 109,744
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 (6)
- Lot #: LN10686
- LN10687
- LN10688
- LN10707
- LN10708
- Exp 02/15
Distribution
Distributed nationwide across the United States.
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