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Recall Observatory FDA recall evidence

Drug product

TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.

D-0121-2026

October 21, 2025

Class II

Product summary

Firm
Kenvue Brands LLC
Event
Event 97850
Status
Ongoing
Classification
Class II
Quantity
3,816 bottles
Official record key
drug-enforcement:D-0121-2026

Official wording

Reason: Defective Container

Code information: Lot: EJA022, expiry: 04/30/2028

Distribution pattern: U.S. Nationwide - CO, IL, OH and IN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container