The Recall Desk
ModerateFDA (Drugs)·D-1355-2014·Announced 2014-06-04

Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to Dissolution Failure

Wockhardt USA LLC is recalling 8,712 bottles of Metoprolol Succinate Extended-Release Tablets, 100 mg, because they failed dissolution testing.

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 typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is a failure to meet specifications (dissolution) rather than a direct physical injury or contamination, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Wockhardt USA LLC is voluntarily recalling 8,712 bottles of Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottles. The product is prescription-only and was distributed nationwide. The specific lot number is LN11423, with an expiration date of 8/15/15.

The recall was initiated because the product failed to meet dissolution specifications. Specifically, a failure of the dissolution test was observed at the three-month time point. This means the tablets may not release the medication as intended, potentially affecting the drug's efficacy.

Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using this specific lot.

The recalled product

Product
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Cardiovascular
Hazard
Affected units
8,712

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 (2)

  • Lot #: LN11423
  • Expiry: 8/15/15

Distribution

Distributed nationwide across the United States.

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