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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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