Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Class I - DangerousWhat Should You Do?
- Check if you have this product: A) Lot #: LM10843, Expiry: 5/31/2015; Lot #: LM11331, Expiry: 7/31/2015; Lot #: LM11332, Expiry: 7/31/2015; Lot #: LM11376, Expiry: 7/31/2015; Lot #: LM11583, Expiry: 8/31/2015; Lot #: LM11987, Expiry: 11/30/2015; Lot #: LN10065, Expiry: 12/31/2015; Lot #: LN10066, Expiry: 12/31/2015; Lot #: LN10334, Expiry: 1/31/2016; Lot #: LN10335, Expiry: 1/31/2016; Lot #: LN10443, Expiry: 1/31/2016; Lot #: LN10879, Expiry: 4/30/2016; Lot #: LN10971, Expiry: 4/30/2016; Lot #: LN11178, Expiry: 6/30/2016; Lot #: LN11184, Expiry: 6/30/2016; Lot #: LN11348, Expiry: 7/31/2016. B) Lot #: LM10683, Expiry: 4/30/2015; Lot #: LM10842, Expiry: 5/31/2015; Lot #: LM11377, Expiry: 7/31/2015; Lot #: LM11584, Expiry: 8/31/2015; Lot #: LM11985, Expiry: 11/30/2015; Lot #: LM11988, Expiry: 11/30/2015; Lot #: LN10064, Expiry: 12/31/2015; Lot #: LN10336, Expiry: 1/31/2016; Lot #: LN10446, Expiry: 1/31/2016; Lot #: LN10880, Expiry: 4/30/2016; Lot #: LN10883, Expiry: 4/30/2016; Lot #: LN10972, Expiry: 4/30/2016; Lot #: LN11177, Expiry: 6/30/2016; Lot #: LN11256, Expiry: 7/31/2016.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), 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 #: LM10843, Expiry: 5/31/2015; Lot #: LM11331, Expiry: 7/31/2015; Lot #: LM11332, Expiry: 7/31/2015; Lot #: LM11376, Expiry: 7/31/2015; Lot #: LM11583, Expiry: 8/31/2015; Lot #: LM11987, Expiry: 11/30/2015; Lot #: LN10065, Expiry: 12/31/2015; Lot #: LN10066, Expiry: 12/31/2015; Lot #: LN10334, Expiry: 1/31/2016; Lot #: LN10335, Expiry: 1/31/2016; Lot #: LN10443, Expiry: 1/31/2016; Lot #: LN10879, Expiry: 4/30/2016; Lot #: LN10971, Expiry: 4/30/2016; Lot #: LN11178, Expiry: 6/30/2016; Lot #: LN11184, Expiry: 6/30/2016; Lot #: LN11348, Expiry: 7/31/2016. B) Lot #: LM10683, Expiry: 4/30/2015; Lot #: LM10842, Expiry: 5/31/2015; Lot #: LM11377, Expiry: 7/31/2015; Lot #: LM11584, Expiry: 8/31/2015; Lot #: LM11985, Expiry: 11/30/2015; Lot #: LM11988, Expiry: 11/30/2015; Lot #: LN10064, Expiry: 12/31/2015; Lot #: LN10336, Expiry: 1/31/2016; Lot #: LN10446, Expiry: 1/31/2016; Lot #: LN10880, Expiry: 4/30/2016; Lot #: LN10883, Expiry: 4/30/2016; Lot #: LN10972, Expiry: 4/30/2016; Lot #: LN11177, Expiry: 6/30/2016; Lot #: LN11256, Expiry: 7/31/2016.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1275-2015
Related Recalls
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.