Acetaminophen recalls

The FDA has published 46 recalls involving Acetaminophen since 2013. The latest was reported on 5 Nov 2025. Most were for manufacturing (cgmp) deviations. Perrigo Company has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls46since 2013

Last 12 months1reported

Class I37% of total

Ongoing7latest 5 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 1 0Jul 0 1 0Oct 1 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 3 7%Class II 43 93%Class III 0 0%

Why acetaminophen is recalled

Companies

Brands

By year

202537%
202437%
202337%
20222350%
202149%
202049%
201812%
2013511%

Ongoing acetaminophen recalls

7 active

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Drug	CLASS II	Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength	Kenvue Brands	Other	Nationwide
3 Sep 2025Drug	CLASS II	Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen	Baxter Healthcare	Packaging Defects	Nationwide
25 Jun 2025Drug	CLASS II	Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
28 Aug 2024Drug	CLASS I	Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen	Hikma Pharmaceuticals USA	Packaging Defects	OH, PR
3 Jul 2024Drug	CLASS II	Extra Strength Acetaminophen recalled by Contract PharmacalAcetaminophen	Contract Pharmacal	Other	MI
13 Dec 2023Drug	CLASS II	KinderMed Kids' Pain & Fever Acetaminophen, 160 mg recalledPain And Fever	Kinder Farms	Potency & Assay	Nationwide

All acetaminophen recalls, newest first

46 total

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Drug	CLASS II	Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength	Kenvue Brands	Other	Nationwide
3 Sep 2025Drug	CLASS II	Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen	Baxter Healthcare	Packaging Defects	Nationwide
25 Jun 2025Drug	CLASS II	Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
28 Aug 2024Drug	CLASS I	Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen	Hikma Pharmaceuticals USA	Packaging Defects	OH, PR
14 Aug 2024Drug	CLASS I	Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen	A-S Medication Solutions	Labeling Errors	Nationwide
3 Jul 2024Drug	CLASS II	Extra Strength Acetaminophen recalled by Contract PharmacalAcetaminophen	Contract Pharmacal	Other	MI
13 Dec 2023Drug	CLASS II	KinderMed Kids' Pain & Fever Acetaminophen, 160 mg recalledPain And Fever	Kinder Farms	Potency & Assay	Nationwide
13 Dec 2023Drug	CLASS II	KinderMed Infants' Pain & Fever Acetaminophen, 160 mg recalledInfants Pain And Fever	Kinder Farms	Potency & Assay	Nationwide
31 May 2023Drug	CLASS II	Pain Reliever, Acetaminophen USP Caplets, 500 mg recalledPain Reliever	Aurobindo Pharma USA	Potency & Assay	Nationwide
14 Sep 2022Drug	CLASS II	Acetaminophen Oral Solution 650 mg / cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Acetaminophen?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.