The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1247-2015·Announced 2015-07-29

Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures

Wockhardt USA is recalling Zolpidem Tartrate 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 involves a reasonable probability of temporary or medically reversible health consequences. The specific hazard is a documentation and process failure (failure to investigate complaints) rather than a direct physical or chemical defect, aligning with the 'Moderate' criteria for minor labeling or process errors without reported acute injury.

Plain-English summary

Wockhardt USA LLC is recalling Zolpidem Tartrate Tablets, 5 mg, packaged in 100 tablet bottles. The product is a prescription-only medication (CIV) 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 are DM11802, DM11803, DM12273, and DM12274, with expiration dates of June 30, 2015, or July 31, 2015.

A total of 37,791 bottles were distributed nationwide in the United States, including Puerto Rico. Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
37,791

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 (7)

  • Lot #: DM11802
  • Expiry: 6/30/2015
  • Lot #: DM11803
  • Lot #: DM12273
  • Expiry: 7/31/2015
  • Lot #: DM12274
  • Expiry: 7/31/2015.

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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