The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1273-2015·Announced 2015-07-29

Wockhardt Recalls Zonisamide Capsules Due to Complaint Investigation Failures

Wockhardt USA is recalling 84,542 bottles of Zonisamide 50 mg capsules 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 due to CGMP deviations regarding complaint investigation. As no specific adverse health consequences or illnesses are reported in the source text, and the hazard is procedural rather than a direct contamination or defect causing immediate harm, it aligns with the 'Moderate' severity criteria for minor labeling or procedural errors.

Plain-English summary

Wockhardt USA LLC is recalling 84,542 bottles of Zonisamide Capsules, 50 mg, packaged in 100-count bottles. The product is prescription-only and was distributed nationwide, 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 failed to adequately investigate customer complaints. The affected lots have expiration dates ranging from April 30, 2015, to August 31, 2016.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on obtaining a replacement. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Zonisamide Capsules, 50 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: 64679-0946-01.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Anticonvulsant
Hazard
Affected units
84,542

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 #: LM10769
  • Expiry: 4/30/2015
  • Lot #: LM10770
  • Lot #: LM10771
  • Lot #: LM10875
  • Expiry: 5/31/2015
  • Lot #: LM10876
  • Lot #: LM11145
  • Expiry: 6/30/2015
  • Lot #: LM11174
  • Lot #: LM11175
  • Lot #: LM11226
  • Expiry: 7/31/2015
  • Lot #: LM11227
  • Lot #: LM11289
  • Lot #: LM11290
  • Lot #: LM11544
  • Expiry: 8/31/2015
  • Lot #: LM11545
  • Lot #: LM11671

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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