FDA Drug Recalls

Recalls / Active ingredient / Acetaminophen

Acetaminophen

54 FDA drug recalls involving the active ingredient “Acetaminophen5 Class I.

DateClassProductFirm
2025-12-16Class IIOxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MOSpecGx, LLC
2025-12-16Class IIOxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, SpecGx, LLC
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
2025-03-13Class IIAcetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-Glenmark Pharmaceuticals Inc., USA
2024-07-11Class IHealthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottleAurobindo 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
2024-02-16Class IIBroncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, Global Corporation
2023-11-13Class IIKinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry FlavorKINDER FARMS LLC
2023-11-13Class IIKinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4KINDER FARMS LLC
2023-05-22Class IIPain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, DistributeAurobindo Pharma USA Inc.
2022-10-11Class IIINDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COLNK International, 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
2021-11-19Class IIHydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured foAscent Pharmaceuticals, 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.
2021-11-01Class IIAcetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-5Precision Dose Inc.
2021-10-26Class 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 Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle,Perrigo 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 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 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 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 IIChildren's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed Perrigo Company PLC
2021-08-24Class IIRompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient LaboratEfficient Laboratories, Inc.
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
2020-03-18Class IIAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: AuAurobindo Pharma USA Inc.
2020-03-18Class IIAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: AuAurobindo Pharma USA Inc.
2020-03-18Class IIAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: AuAurobindo Pharma USA Inc.
2020-03-18Class IIOxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo PAurobindo Pharma USA Inc.
2020-02-03Class IIMajor Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottlContract Pharmacal Corporation
2018-05-24Class IIIHydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured byLUPIN SOMERSET
2018-04-24Class IIAcetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for:Prescript Pharmaceuticals, Inc.
2015-04-15Class IMucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, DextromReckitt Benckiser LLC
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, 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 cherry flavor, co-packaged with an oral dosing syringe L. Perrigo Co.
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.
2013-06-18Class IITheraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hNovartis Consumer Health
2012-04-26Class IIIMidol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by BayeBayer Healthcare, LLC
2012-04-26Class IIIMidol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16Bayer Healthcare, LLC