The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1267-2015·Announced 2015-07-29

Wockhardt Recalls Famotidine Tablets Due to Complaint Investigation Failures

Wockhardt USA LLC is recalling 1,002 drums of Famotidine Tablets, USP, 10 mg 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 temporary or medically reversible adverse health consequence. The specific issue is a documentation and process failure (failure to investigate complaints) rather than a direct contamination or defect causing immediate harm, fitting the 'Moderate' criteria for minor labeling or process errors without reported injury.

Plain-English summary

Wockhardt USA LLC is voluntarily recalling 1,002 drums of Famotidine Tablets, USP, 10 mg, packaged in 50,000-count drums for repacking only. The product is Over the Counter and was distributed nationwide in the United States, including Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The affected lots include LM10826, LM10999, LM11016, LM11032, LM11038, LM11087, LM11149, LM11156, LM11615, LN10195, LN10323, LN10500, LN10507, LN10514, LN10555, LN10556, LN10565, LN10784, LN10788, LN10831, LN10839, LN10846, LN10856, LN10884, LN10916, LN10931, LN10934, LN11067, and LN11072.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or disposed of according to local regulations. No specific health risks or illnesses have been reported in the source text.

The recalled product

Product
Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Tablets
Hazard
Affected units
1,002

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)

  • Lot #: LM10826
  • Expiry: 5/31/2015
  • Lot #: LM10999
  • Lot #: LM11016
  • Expiry: 6/30/2015
  • Lot #: LM11032
  • Lot #: LM11038
  • Lot #: LM11087
  • Lot #: LM11149
  • Expiry: 4/30/2015
  • Lot #: LM11156
  • Lot #: LM11615
  • Expiry: 8/31/2015
  • Lot #: LN10195
  • Expiry: 12/31/2015
  • Lot #: LN10323
  • Lot #: LN10500
  • Expiry: 1/31/2016
  • Lot #: LN10507
  • Lot #: LN10514

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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