The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1248-2015·Announced 2015-07-29

Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

Wockhardt USA Inc. is recalling Azithromycin Tablets, USP, 250 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, and the source text identifies a CGMP deviation regarding complaint investigation without reporting specific illnesses, injuries, or deaths, aligning with the criteria for a moderate severity score.

Plain-English summary

Wockhardt USA Inc. is voluntarily recalling Azithromycin Tablets, USP, 250 mg, in 30-count bottles, 3,500-count pouches, and 3 x 6 tablet card cartons. The recall was initiated because the firm did not adequately investigate customer complaints, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected products were distributed nationwide in the United States, including Puerto Rico. The recall includes specific lot numbers with expiration dates ranging from April 30, 2015, to September 30, 2016. The total quantity recalled is 280,520 bottles, 571 pouches, and 1,629,253 cartons.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by…
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Antibiotic
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 #: LM10712
  • Expiry: 4/30/2015
  • Lot #: LM10874
  • Lot #: LM11040
  • Expiry: 5/31/2015
  • Lot #: LM11169
  • Expiry: 6/30/2015
  • Lot #: LM11401
  • Lot #: LM12132
  • Expiry: 11/30/2015
  • Lot #: LN10039
  • Expiry: 12/31/2015
  • Lot #: LN10263
  • Lot #: LN10276
  • Lot #: LN10417
  • Expiry: 1/31/2016
  • Lot #: LN11365
  • Expiry: 8/31/2016. B) Lot #: LN11264
  • Expiry: 7/31/2015
  • Lot #: LN11373

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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