Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failures
Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution testing. The recall covers 11,661 bottles distributed nationwide.
What this means for you
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 involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct physical injury or contamination, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Wockhardt USA LLC is recalling 11,661 bottles of Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg. The affected products are available in 100-count and 500-count bottles and were distributed nationwide. The specific lots involved are LN11005, LN11006, LN10979, and LN10980, all with an expiration date of 04/15.
The recall was initiated because the tablets failed to meet dissolution specifications during testing of control samples at the four-hour time point. Dissolution is a critical quality attribute that ensures the drug is released from the tablet at the intended rate. If the tablets do not dissolve properly, the medication may not be absorbed into the body as expected, potentially affecting its therapeutic efficacy.
Patients and healthcare providers should check their inventory for the specific NDC numbers (64679-737-02 and 64679-737-03) and lot numbers listed above. If these products are found, they should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider regarding alternative medication options if necessary.
The recalled product
- Product
- Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ
- Manufacturer
- Wockhardt Usa Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 11,661
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 # a) LN11005
- Exp 04/15
- LN11006
- b) LN10979
- Exp. 04/15
- LN10980
Distribution
Distributed nationwide across the United States.
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