Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.

Recall Insight

This FDA Drug action (record #D-0198-2025) was formally reported on January 22, 2025, with the manufacturer initiating the action on December 12, 2024. It is classified under Low severity (Class III), with a current status of Ongoing. Akron Pharma, Inc. is listed as the recalling firm, operating out of Fairfield, NJ. Federal records indicate 456 bottles units are affected.

The documented reason for this recall is: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Distribution data in the federal record shows the product reached: Nationwide in the US. 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 1 year 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.