Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01

Recall Insight

This FDA Drug action (record #D-856-2013) was formally reported on August 14, 2013, with the manufacturer initiating the action on May 21, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. American Health Packaging is listed as the recalling firm, operating out of Columbus, OH. Federal records indicate 48.230 carton units units are affected.

The documented reason for this recall is: Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet. Distribution data in the federal record shows the product reached: Nationwide.. 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 13 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.