CLASS II ONGOING Drug recall · Reported 5 Nov 2025 · FDA Enforcement Report
Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalled
Kenvue Brands is recalling Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed nationwide in the US. The recall was initiated on 21 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0121-2026
- FDA event ID
- 97850
- Recalling firm
- Kenvue Brands, Summitt, NJ
- Manufacturer
- Kenvue Brands LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Oct 2025
- FDA classified
- 28 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 21 Oct 2025 | Recall initiated by company | |
| 28 Oct 2025 | Classified by FDA | +7 days |
| 5 Nov 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide - CO, IL, OH and IN.
Questions about this recall
Why was it recalled?
Defective Container
Which lots are affected?
Lot: EJA022, expiry: 04/30/2028
Where was it sold?
U.S. Nationwide - CO, IL, OH and IN.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Acetaminophen recalls
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|---|---|---|---|---|---|
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |