PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L

Recall Insight

This FDA Drug action (record #D-0327-2022) was formally reported on January 12, 2022, with the manufacturer initiating the action on November 29, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. ULTRAtab Laboratories, Inc. is listed as the recalling firm, operating out of Highland, NY. Federal records indicate 14 bulk lots (approximately 1,987,951 tablets each) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: CGMP Deviations: failed stability results, inadequate laboratory investigations, Distribution data in the federal record shows the product reached: Product was distributed to one customer who may have further distributed the product.. 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 4 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.