Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Class I - Dangerous
💊 Drugs Recalled: April 22, 2015 Wockhardt Usa Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    A) Lot #: LM11093, Expiry: 6/30/2015; Lot #: LM11335, Expiry: 7/31/2015; Lot #: LM11336, Expiry: 7/31/2015; Lot #: LM11461, Expiry: 8/31/2015; Lot #: LM11462, Expiry: 8/31/2015; Lot #: LM11579, Expiry: 8/31/2015; Lot #: LM11778, Expiry: 9/30/2015; Lot #: LM11995, Expiry: 11/30/2015; Lot #: LN10029, Expiry: 11/30/2015; Lot #: LN10071, Expiry: 12/31/2015; Lot #: LN10349, Expiry: 1/31/2016; Lot #: LN10350, Expiry: 1/31/2016; Lot #: LN10505, Expiry: 2/29/2016; Lot #: LN10506, Expiry: 2/29/2016; Lot #: LN10814, Expiry: 3/31/2016; Lot #: LN10815, Expiry: 3/31/2016; Lot #: LN10977, Expiry: 4/30/2016; Lot #: LN11156, Expiry: 6/30/2016; Lot #: LN11260, Expiry: 7/31/2016. B) Lot #: LM10643, Expiry: 4/30/2015; Lot #: LM10846, Expiry: 5/31/2015; Lot #: LM11347, Expiry: 7/31/2015; Lot #: LM11492, Expiry: 8/31/2015; Lot #: LM11493, Expiry: 8/31/2015; Lot #: LM11577, Expiry: 8/31/2015; Lot #: LM11732, Expiry: 9/30/2015; Lot #: LM11994, Expiry: 11/30/2015; Lot #: LN10072, Expiry: 12/31/2015; Lot #: LN10073, Expiry: 12/31/2015; Lot #: LN10351, Expiry: 1/31/2016; Lot #: LN10561, Expiry: 2/29/2016; Lot #: LN10562, Expiry: 2/29/2016; Lot #: LN10816, Expiry: 3/31/2016; Lot #: LN10817, Expiry: 4/30/2016; Lot #: LN11162, Expiry: 6/30/2016; Lot #: LN11170, Expiry: 6/30/2016; Lot #: LN11171, Expiry: 6/30/2016.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Wockhardt Usa Inc.
Reason for Recall:
CGMP Deviations: Firm did not adequately investigate customer complaints.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Product Codes/Lot Numbers:

A) Lot #: LM11093, Expiry: 6/30/2015; Lot #: LM11335, Expiry: 7/31/2015; Lot #: LM11336, Expiry: 7/31/2015; Lot #: LM11461, Expiry: 8/31/2015; Lot #: LM11462, Expiry: 8/31/2015; Lot #: LM11579, Expiry: 8/31/2015; Lot #: LM11778, Expiry: 9/30/2015; Lot #: LM11995, Expiry: 11/30/2015; Lot #: LN10029, Expiry: 11/30/2015; Lot #: LN10071, Expiry: 12/31/2015; Lot #: LN10349, Expiry: 1/31/2016; Lot #: LN10350, Expiry: 1/31/2016; Lot #: LN10505, Expiry: 2/29/2016; Lot #: LN10506, Expiry: 2/29/2016; Lot #: LN10814, Expiry: 3/31/2016; Lot #: LN10815, Expiry: 3/31/2016; Lot #: LN10977, Expiry: 4/30/2016; Lot #: LN11156, Expiry: 6/30/2016; Lot #: LN11260, Expiry: 7/31/2016. B) Lot #: LM10643, Expiry: 4/30/2015; Lot #: LM10846, Expiry: 5/31/2015; Lot #: LM11347, Expiry: 7/31/2015; Lot #: LM11492, Expiry: 8/31/2015; Lot #: LM11493, Expiry: 8/31/2015; Lot #: LM11577, Expiry: 8/31/2015; Lot #: LM11732, Expiry: 9/30/2015; Lot #: LM11994, Expiry: 11/30/2015; Lot #: LN10072, Expiry: 12/31/2015; Lot #: LN10073, Expiry: 12/31/2015; Lot #: LN10351, Expiry: 1/31/2016; Lot #: LN10561, Expiry: 2/29/2016; Lot #: LN10562, Expiry: 2/29/2016; Lot #: LN10816, Expiry: 3/31/2016; Lot #: LN10817, Expiry: 4/30/2016; Lot #: LN11162, Expiry: 6/30/2016; Lot #: LN11170, Expiry: 6/30/2016; Lot #: LN11171, Expiry: 6/30/2016.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1276-2015

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