The Recall Desk
ModerateFDA (Drugs)·D-1256-2015·Announced 2015-07-29

Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

Wockhardt USA is recalling Amlodipine Besylate 10 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 remote possibility of temporary or medically reversible health consequences. The specific deviation is a documentation/investigation failure (CGMP) rather than a confirmed contamination or defect causing injury, aligning with the 'Moderate' severity criteria for minor labeling or process errors without reported harm.

Plain-English summary

Wockhardt USA Inc. is recalling Amlodipine Besylate Tablets, 10 mg, in 90-count and 1,000-count bottles. The product is manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt USA LLC in Parsippany, New Jersey.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The affected lots were distributed nationwide in the United States, including Puerto Rico.

Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the medication matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 U
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard

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 (20)

  • A) Lot #: DM12975
  • Expiry: 10/31/2015
  • Lot #: DM12976
  • Lot #: DM12977
  • Expiry:10/31/2015
  • Lot #: DM12986
  • Lot #: DM13259. Expiry: 10/31/2015
  • Lot #: DM13269
  • Lot #: DM13270
  • Expiry: 11/30/2015
  • Lot #: DM13275
  • Lot #: DM13339
  • Lot #: DM13341
  • Lot #: DM13369
  • Lot #: DM13370
  • Lot #: DN10088
  • Expiry: 12/31/2015
  • Lot #: DN10099
  • Lot #: DN10939
  • Expiry: 3/31/2016

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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