The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1255-2015·Announced 2015-07-29

Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

Wockhardt USA is recalling Amlodipine Besylate 5 mg tablets because the firm did not adequately investigate customer complaints.

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 typically indicates a reasonable probability of temporary or medically reversible health consequences. The specific deviation is a documentation/investigation failure (CGMP) rather than a direct physical hazard like contamination or mislabeling, fitting the Moderate severity criteria for minor labeling or documentation issues.

Plain-English summary

Wockhardt USA LLC is recalling Amlodipine Besylate Tablets, 5 mg, in 90-count and 1,000-count bottles. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically because the firm did not adequately investigate customer complaints.

The affected product is distributed nationwide in the United States, including Puerto Rico. The recall includes specific lot numbers with expiration dates ranging from April 2015 to March 2016. The total quantity involved is 146,959 bottles of the 90-count packaging and 73,445 bottles of the 1,000-count packaging.

Consumers with these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054…
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Antihypertensive
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 #: DM11421
  • Expiry: 5/31/2015
  • Lot #: DM12956
  • Expiry: 10/31/2015
  • Lot #: DM12957
  • Lot #: DM12963
  • Lot #: DM13242
  • Expiry: 11/30/2015
  • Lot #: DM13243
  • Lot #: DM13251
  • Lot #: DM13260
  • Lot #: DN10138
  • Expiry: 12/31/2015. B) Lot #: DM11035
  • Expiry: 4/30/2015
  • Lot #: DM11088
  • Lot #: DM11389
  • Lot #: DM11393
  • Lot #: DM11394
  • Lot #: DM12632
  • Expiry: 9/30/2015

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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