FDA Drug Recalls

Recalls / Generics / Acetaminophen

Acetaminophen

36 FDA drug recalls involving generic “Acetaminophen3 Class I.

DateClassProductFirm
2025-10-21Class IITYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer IncKenvue Brands LLC
2025-08-20Class IIAcetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter HealthBaxter Healthcare Corporation
2025-05-22Class IIAcetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N.Aurobindo Pharma USA Inc
2024-07-08Class IAcetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, RxHikma Pharmaceuticals USA Inc.
2024-06-21Class IAcetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, LA-S Medication Solutions LLC
2024-05-20Class IIExtra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N LContract Pharmacal Corporation
2023-11-13Class IIKinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4KINDER FARMS LLC
2023-11-13Class IIKinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry FlavorKINDER FARMS LLC
2023-05-22Class IIPain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, DistributeAurobindo Pharma USA Inc.
2022-08-04Class IIAcetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For InBaxter Healthcare Corporation
2021-11-01Class IIAcetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-5Precision Dose Inc.
2021-11-01Class IIAcetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a)Precision Dose Inc.
2021-10-26Class IIInfant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY:Perrigo Company PLC
2021-10-26Class IIAcetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, DistributePerrigo Company PLC
2021-10-26Class IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTPerrigo Company PLC
2021-10-26Class IIAcetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack, Perrigo Company PLC
2021-10-26Class IIChildren's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed Perrigo Company PLC
2021-10-26Class IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DistributPerrigo Company PLC
2021-10-26Class IIAcetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THPerrigo Company PLC
2021-10-26Class IIAcetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THPerrigo Company PLC
2021-10-26Class IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTPerrigo Company PLC
2021-10-26Class IIChildren's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED Perrigo Company PLC
2021-10-26Class IIAcetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: WPerrigo Company PLC
2021-10-26Class IIAcetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, DistributePerrigo Company PLC
2021-10-26Class IIChildren's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed Perrigo Company PLC
2021-10-26Class IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTPerrigo Company PLC
2021-10-26Class IIAcetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by TaPerrigo Company PLC
2021-10-26Class IIChildren's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed Perrigo Company PLC
2021-10-26Class IIChildren's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle,Perrigo Company PLC
2021-03-02Class IAcetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, LiA-S Medication Solutions LLC.
2020-12-30Class IIAcetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, DisAuroMedics Pharma LLC
2020-02-03Class IIMajor Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottlContract Pharmacal Corporation
2013-11-01Class IIAcetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dL. Perrigo Co.
2013-11-01Class IIAcetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral doL. Perrigo Co.
2013-11-01Class IIAcetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with aL. Perrigo Co.
2013-11-01Class IIAcetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe L. Perrigo Co.