The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1253-2015·Announced 2015-07-29

Wockhardt Recalls Tamsulosin Hydrochloride Capsules Due to CGMP Deviations

Wockhardt USA Inc. is recalling Tamsulosin Hydrochloride Capsules because the firm did not adequately investigate customer complaints, a Current Good Manufacturing Practice (CGMP) deviation.

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, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific deviation is a procedural failure (inadequate complaint investigation) rather than a confirmed contamination or defect causing injury, fitting the Moderate severity criteria for low-risk or procedural issues.

Plain-English summary

Wockhardt USA Inc. is recalling Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, packaged in 100-count and 500-count bottles. The product is manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt USA LLC in Parsippany, New Jersey. The recall covers 407,958 bottles distributed nationwide, including Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. This procedural failure raises concerns about the quality control processes used to ensure the safety and efficacy of the medication.

Consumers who have purchased these specific lots of Tamsulosin Hydrochloride Capsules should stop using the product and contact their healthcare provider or pharmacist for guidance. The affected lots have expiration dates ranging from April 30, 2015, to September 30, 2015.

The recalled product

Product
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd.…
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
407,958

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 #: LN10896
  • Expiry: 4/30/2015
  • Lot #: LN10901
  • Lot #:LN10902
  • Lot #: LN10903
  • Lot #: LN11020
  • Expiry: 5/31/2015
  • Lot #: LN11021
  • Lot #: LN11055
  • Lot #: LN11056
  • Lot #: LN11149
  • Lot #: LN11150
  • Lot #: LN11267
  • Expiry: 6/30/2015
  • Lot #: LN11357
  • Expiry: 7/31/2015
  • Lot #: LN11387
  • Expiry: 8/31/2015
  • Lot #: LN11421
  • Expiry: 9/30/2015. B) Lot #: LN10808

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 →

Related recalls

Same manufacturer · Wockhardt Usa Inc.

See all →

Same hazard · cgmp deviation

See all →

Similar recalls