Acetaminophen recalls

The FDA has published 61 recalls involving Acetaminophen since 2012. The latest was reported on 5 Nov 2025. Most were for manufacturing (cgmp) deviations. Perrigo 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 recalls61since 2012

Last 12 months1reported

Class I58% of total

Ongoing7latest 5 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 1 0 0Feb 0 1 0May 1 0 0Aug 1 0 1Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 5 8%Class II 51 84%Class III 5 8%

Why acetaminophen is recalled

Companies

Brands

By year

202547%
2024610%
202312%
20222439%
202158%
202047%
201823%
201712%
201535%
201458%

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
16 Apr 2025Drug	CLASS II	Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen	Glenmark Pharmaceuticals Inc., 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
28 Aug 2024Drug	CLASS I	Healthy Living Acetaminophen, Aspirin (Nsaid) and Caffeine recalledAcetaminophen Aspirin And Caffeine	Aurobindo Pharma USA	Labeling Errors	NJ, NY, PA

All acetaminophen recalls, newest first

61 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
16 Apr 2025Drug	CLASS II	Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
18 Dec 2024Drug	CLASS II	Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion	LNK International	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
28 Aug 2024Drug	CLASS I	Healthy Living Acetaminophen, Aspirin (Nsaid) and Caffeine recalledAcetaminophen Aspirin And Caffeine	Aurobindo Pharma USA	Labeling Errors	NJ, NY, PA
14 Aug 2024Drug	CLASS I	Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen	A-S Medication Solutions	Labeling Errors	Nationwide
14 Aug 2024Drug	CLASS III	Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer recalled	Granules Consumer Health	Labeling Errors	IL
3 Jul 2024Drug	CLASS II	Extra Strength Acetaminophen recalled by Contract PharmacalAcetaminophen	Contract Pharmacal	Other	MI
31 May 2023Drug	CLASS II	Pain Reliever, Acetaminophen USP Caplets, 500 mg recalledPain Reliever	Aurobindo Pharma USA	Potency & Assay	Nationwide
26 Oct 2022Drug	CLASS III	LNK International products recalledSinus Pressure, Pain And Cough	LNK International	Labeling Errors	Nationwide
14 Sep 2022Drug	CLASS II	Acetaminophen Oral Solution 650 mg / cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide
14 Sep 2022Drug	CLASS II	Acetaminophen Oral Solution, 325 mg / cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide
14 Sep 2022Drug	CLASS II	Acetaminophen Oral Solution 160 mg / cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide
24 Aug 2022Drug	CLASS II	Acetaminophen Injection, 10 mg/mL recalled by Baxter HealthcareAcetaminophen	Baxter Healthcare	Temperature Abuse	Nationwide
24 Aug 2022Drug	CLASS III	Acetaminophen 325 mg tablets, packaged in a) 100-count bottle recalled	Akron Pharma	Packaging Defects	NJ
25 May 2022Drug	CLASS II	Acetaminophen Oral Solution, USP 650mg/ cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	IN
2 Mar 2022Drug	CLASS II	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg recalledInfants Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Acetaminophen Child Bubble Gum Flavored Oral Suspension recalledEquate Childrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Children's Grape Flavored Acetaminophen Oral Suspension (160mg recalledUp And Up Childrens Acetaminophen	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Acetaminophen Child Dye Free Cherry Flavor Oral Suspension recalledChildrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg recalledParents Choice Infants Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Children's Grape Flavored Acetaminophen Oral Suspension (160mg recalledEquate Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Children's Grape Flavored Acetaminophen Oral Suspension (160mg recalledDg Health Childrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg recalledInfants Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Children's Grape Flavored Acetaminophen Oral Suspension (160mg recalledRugby Childrens Acetaminophen	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Acetaminophen Child Dye Free Cherry Flavor Oral Suspension recalledEquate Childrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg recalledUp And Up Acetaminophen	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Acetaminophen Child Dye Free Cherry Flavor Oral Suspension recalledChildrens Pain And Fever	Perrigo	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.