The Recall Desk
ModerateFDA (Drugs)·D-1243-2015·Announced 2015-07-29

Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

Wockhardt USA LLC is recalling Amlodipine Besylate 2.5 mg tablets because the firm did not adequately investigate customer complaints.

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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific deviation is a procedural failure in complaint investigation rather than a confirmed contamination or defect causing immediate harm.

Plain-English summary

Wockhardt USA LLC is recalling Amlodipine Besylate Tablets, 2.5 mg, packaged in 90-count bottles. The product is prescription-only and was distributed nationwide in the United States, including Puerto Rico. The recall involves 124,034 bottles across multiple lots with expiration dates ranging from June 2015 to January 2016.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. This procedural failure raises concerns about the quality control processes used to ensure the safety and efficacy of the medication.

Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on how to dispose of the product or obtain a replacement. The specific lot numbers and expiration dates are listed in the official recall notice to help identify affected inventory.

The recalled product

Product
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
124,034

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 (18)

  • Lot #: DM11774
  • Expiry: 6/30/2015
  • Lot #: DM13056
  • Expiry: 10/31/2015
  • Lot #: DM13117
  • Lot #: DM13159
  • Lot #: DM13186
  • Lot #: DM13187
  • Lot #: DM13188
  • Lot #: DN10003
  • Expiry: 11/30/2015
  • Lot #: DN10045
  • Lot #: DN10046
  • Lot #: DN10389
  • Expiry: 1/31/2016
  • Lot #: DN10412
  • Lot #: DN10604
  • Expiry: 1/31/2016.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 35 recalled by Wockhardt Usa Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 35 products in this recall →

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