The Recall Desk
ModerateFDA (Drugs)·D-1277-2015·Announced 2015-07-29

Wockhardt Recalls Captopril Tablets Due to Complaint Investigation Failures

Wockhardt USA is recalling 68,969 bottles of Captopril 100 mg tablets because the firm did not adequately investigate customer complaints.

What this means for you

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 and involves a CGMP deviation regarding complaint investigation. There are no reported illnesses or injuries, and the hazard is procedural rather than a direct physical defect, fitting the Moderate severity criteria for low-risk or voluntary precautionary recalls.

Plain-English summary

Wockhardt USA LLC is recalling 68,969 bottles of Captopril Tablets, USP, 100 mg. The product is packaged in 100-count bottles and is available by prescription only. The tablets 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 include LM11354, LM11355, LM11374, LM11626, LM12004, LM12005, LN10080, LN10393, LN10447, LN10736, and LN11316, with expiration dates ranging from July 31, 2015, to July 31, 2016.

The product was distributed nationwide in the United States, including Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Captopril Tablets, USP, 100 mg Tablets, 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: 64679-0905-01.
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
68,969

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 (18)

  • Lot #: LM11354
  • Expiry: 7/31/2015
  • Lot #: LM11355
  • Lot #: LM11374
  • Lot #: LM11626
  • Expiry: 8/31/2015
  • Lot #: LM12004
  • Expiry: 11/30/2015
  • Lot #: LM12005
  • Lot #: LN10080
  • Expiry: 10/31/2015
  • Lot #: LN10393
  • Expiry: 1/31/2016
  • Lot #: LN10447
  • Lot #: LN10736
  • Expiry: 2/29/2016
  • Lot #: LN11316
  • Expiry: 7/31/2016.

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 →