Acetaminophen recalls

Acetaminophen products have been recalled 10 times, most recently on 3 Sep 2025. The recalling company is usually Precision Dose. The most common reason is packaging defects.

Total recalls10since 2020

Last 12 months0reported

Class I330% of total

Ongoing3latest 3 Sep 2025

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 3 30%Class II 7 70%Class III 0 0%

Why acetaminophen is recalled

Companies

Product types

Pain Medication10100%

By year

2025110%
2024330%
2022110%
2021440%
2020110%

Ongoing acetaminophen recalls

3 active

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Drug	CLASS II	Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen	Baxter Healthcare	Packaging Defects	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

All acetaminophen recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Drug	CLASS II	Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen	Baxter Healthcare	Packaging Defects	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
24 Aug 2022Drug	CLASS II	Acetaminophen Injection, 10 mg/mL recalled by Baxter HealthcareAcetaminophen	Baxter Healthcare	Temperature Abuse	Nationwide
17 Nov 2021Drug	CLASS II	Acetaminophen Oral Suspension, 160 mg recalled by Precision DoseAcetaminophen	Precision Dose	Manufacturing (CGMP) Deviations	Nationwide
17 Nov 2021Drug	CLASS II	Acetaminophen Oral Suspension, 325 mg recalled by Precision DoseAcetaminophen	Precision Dose	Manufacturing (CGMP) Deviations	Nationwide
12 May 2021Drug	CLASS I	Acetaminophen, Extra Strength, Aspirin Free, Mfr recalledAcetaminophen	A-S Medication Solutions	Packaging Defects	Nationwide
10 Feb 2021Drug	CLASS II	Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen	AuroMedics Pharma	Other	Nationwide
19 Feb 2020Drug	CLASS II	Major Extra Strength Acetaminophen Tablets recalledAcetaminophen	Contract Pharmacal	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.