The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1251-2015·Announced 2015-07-29

Wockhardt Recalls 15 mg Lansoprazole Capsules Due to Complaint Investigation Failures

Wockhardt USA is recalling 848 pouches of 15 mg Lansoprazole Delayed-Release 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. No specific health hazards, illnesses, or injuries are reported in the source text, fitting the criteria for a moderate severity voluntary or administrative recall.

Plain-English summary

Wockhardt USA Inc. is recalling 848 pouches of Lansoprazole Delayed-Release Capsules, USP, 15 mg. The product is packaged in 4500-count pouches for repackaging only and is available over the counter. The specific lot number is LN11086, with an expiration date of 5/31/2015.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The agency has classified this recall as Class II.

The product was distributed nationwide in the United States, including Puerto Rico. Consumers should check their inventory for this specific lot number and expiration date. If found, they should contact Wockhardt USA Inc. for instructions on how to return or dispose of the product.

The recalled product

Product
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC…
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription/OTC Medication
Hazard
Affected units
848

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 (2)

  • Lot #: LN11086
  • Expiry: 5/31/2015.

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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