Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30

Recall Insight

This FDA Drug action (record #D-1492-2020) was formally reported on August 19, 2020, with the manufacturer initiating the action on July 14, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Teva Pharmaceuticals USA is listed as the recalling firm, operating out of Parsippany, NJ. Federal records indicate 28,596 cartons units are affected.

The documented reason for this recall is: Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton. Distribution data in the federal record shows the product reached: Nationwide United States. 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. 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 6 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.