Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00

Recall Insight

This FDA Drug action (record #D-0552-2022) was formally reported on February 16, 2022, with the manufacturer initiating the action on January 26, 2022. 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 14,066,434 tablets 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 Distribution data in the federal record shows the product reached: Bulk product was distributed to 3 distributors who may have distributed finished 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.