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.

Recall Insight

This FDA Drug action (record #D-1277-2015) was formally reported on July 29, 2015, with the manufacturer initiating the action on April 22, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Wockhardt Usa Inc. is listed as the recalling firm, operating out of Parsippany, NJ. Federal records indicate 68,969 Bottles units are affected.

The documented reason for this recall is: CGMP Deviations: Firm did not adequately investigate customer complaints. Distribution data in the federal record shows the product reached: U.S. Nationwide including Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.