The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1254-2015·Announced 2015-07-29

Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation

Wockhardt USA LLC is recalling 491,360 bottles of Zonisamide Capsules, 100 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 situation where use of the product may cause 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' criteria for minor labeling or documentation issues.

Plain-English summary

Wockhardt USA LLC is recalling 491,360 bottles of Zonisamide Capsules, 100 mg, packaged in 100-count bottles. The product is prescription-only and was distributed nationwide in the United States, including Puerto Rico. The capsules were 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 have expiration dates ranging from April 30, 2015, to September 30, 2016.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The specific lot numbers are listed in the official recall notice.

The recalled product

Product
Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Anticonvulsant
Hazard
Affected units
491,360

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 #: LM10776
  • Expiry: 5/31/2015
  • Lot #: LM10781
  • Lot #: LM10783
  • Lot #: LM10923
  • Expiry: 4/30/2015
  • Lot #: LM10924
  • Lot #: LM10925
  • Lot #: LM10926
  • Lot #: LM10927
  • Lot #: LM10937
  • Expiry: 6/30/2015
  • Lot #: LM11138
  • Lot #: LM11139
  • Lot #: LM11141
  • Lot #: LM11180
  • Lot #: LM11181
  • Lot #: LM11319
  • Expiry: 7/31/2015
  • Lot #: LM11320

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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