Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India

Recall Insight

This FDA Drug action (record #D-0627-2024) was formally reported on August 14, 2024, with the manufacturer initiating the action on July 18, 2024. It is classified under Low severity (Class III), with a current status of Terminated. Granules Consumer Health Inc. is listed as the recalling firm, operating out of Manassas, VA. Federal records indicate 21,192 Bottles units are affected.

The documented reason for this recall is: Label mix-up: Carton incorrectly labeled. Distribution data in the federal record shows the product reached: Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.. 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 2 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.