The Recall Desk
ModerateFDA (Drugs)·D-0121-2026·Announced 2025-11-05

Extra Strength Tylenol caplets recalled from one lot for defective container

Kenvue Brands is recalling 3,816 bottles of Extra Strength TYLENOL 500mg caplets, 24-count, from one lot because of a defective container.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 as a packaging problem: the record cites a defective container without describing a hazard or reporting harm.

Plain-English summary

TYLENOL Acetaminophen Extra Strength, 24 caplets of 500mg each, distributed by Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division of Fort Washington, Pennsylvania, is being recalled for a defective container.

The recall covers 3,816 bottles from lot EJA022, expiring 30 April 2028, carrying NDC 50580-378-04. The product was distributed in Colorado, Illinois, Ohio and Indiana. The FDA has classified the recall as Class II.

The enforcement record states the container defect without describing its nature or a health consequence, and reports no injuries.

Anyone holding a bottle from the affected lot should follow the retailer's instructions.

The recalled product

Product
TYLENOL EXTRA STRENGTH (ACETAMINOPHEN)
Brand
TYLENOL EXTRA STRENGTH
Manufacturer
Kenvue Brands LLC
Category
Drug — Analgesic
Hazard
Affected units
3,816

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: EJA022
  • expiry: 04/30/2028

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Related recalls

Same hazard · defective container

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