Is Acetaminophen recalled?

240 FDA recalls mention Acetaminophen. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Acetaminophen.

Class III · Low risk Terminated Oct 13, 2021

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0073-2022

Class III · Low risk Terminated Oct 13, 2021

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0072-2022

Class III · Low risk Terminated Oct 13, 2021

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0071-2022

Class III · Low risk Terminated Oct 13, 2021

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0070-2022

Class III · Low risk Terminated Jul 7, 2021

Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by…

Reason Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say…

LNK International, Inc. NDC 46122-649-71 D-0665-2021

Class II · Moderate risk Terminated Jun 16, 2021

Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR…

Reason cGMP deviations: Discolored acetaminophen

Spirit Pharmaceuticals NDC 79903-052-10 D-0729-2021

Class II · Moderate risk Terminated Mar 15, 2021

Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 50580-487-20 D-0497-2021

Class I · High risk Terminated Mar 2, 2021

Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152…

Reason Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled…

A-S Medication Solutions LLC. D-0358-2021

Class II · Moderate risk Terminated Dec 30, 2020

Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by…

Reason Discoloration and failed pH specifications

AuroMedics Pharma LLC NDC 55150-307-01 D-0248-2021

Class III · Low risk Terminated Dec 18, 2020

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown…

Reason Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability…

KVK-Tech, Inc. NDC 10702-344-01 D-0224-2021

Class II · Moderate risk Terminated Oct 26, 2020

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber…

Reason Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium…

Ascent Pharmaceuticals, Inc. NDC 31722-943-01 D-0097-2021

Class III · Low risk Terminated Aug 3, 2020

Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for…

Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

Ultra Seal Corporation D-1513-2020

Class III · Low risk Terminated Aug 3, 2020

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for…

Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

Ultra Seal Corporation D-1512-2020

Class II · Moderate risk Terminated Apr 15, 2020

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle…

Reason cGMP Deviations

H J Harkins Company Inc dba Pharma Pac NDC 52959-0003-10 D-1246-2020

Class II · Moderate risk Terminated Mar 18, 2020

Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc…

Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Aurobindo Pharma USA Inc. NDC 13107-046-01 D-1237-2020

Class II · Moderate risk Terminated Mar 18, 2020

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA…

Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Aurobindo Pharma USA Inc. NDC 13107-060-01 D-1231-2020

Class II · Moderate risk Terminated Mar 18, 2020

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA…

Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Aurobindo Pharma USA Inc. NDC 13107-059-99 D-1230-2020

Class II · Moderate risk Terminated Mar 18, 2020

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA…

Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Aurobindo Pharma USA Inc. NDC 13107-058-01 D-1229-2020

Class II · Moderate risk Terminated Mar 6, 2020

Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c)…

Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength…

H J Harkins Company Inc dba Pharma Pac NDC 52959-0002-30 D-1005-2020

Class II · Moderate risk Terminated Feb 3, 2020

Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC…

Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength…

Contract Pharmacal Corporation NDC 0904-6730-60 D-0858-2020

Class II · Moderate risk Terminated Feb 3, 2020

Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health…

Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength…

Contract Pharmacal Corporation NDC 7000-0036-1 D-0857-2020

Class II · Moderate risk Terminated Jun 24, 2019

Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC…

Reason Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R…

H J Harkins Company Inc dba Pharma Pac NDC 52959-0309-04 D-1429-2019

Class II · Moderate risk Terminated May 21, 2019

Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz…

Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Torrent Pharma Inc D-1366-2019

Class II · Moderate risk Terminated May 21, 2019

Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen…

Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Torrent Pharma Inc NDC 0904-1985-20 D-1348-2019

Class II · Moderate risk Terminated May 21, 2019

Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4…

Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Torrent Pharma Inc D-1346-2019

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