Skip to content

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 II · Moderate risk Terminated Jun 18, 2013

Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health D-763-2014

Class II · Moderate risk Terminated Jun 18, 2013

NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health NDC 0067-7116-06 D-761-2014

Class II · Moderate risk Terminated Jun 18, 2013

NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health D-759-2014

Class II · Moderate risk Terminated Jun 18, 2013

NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health D-758-2014

Class II · Moderate risk Terminated Jun 18, 2013

NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health D-757-2014

Class II · Moderate risk Terminated Jun 18, 2013

Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health NDC 0043-6256-06 D-756-2014

Class II · Moderate risk Terminated Jun 18, 2013

Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health NDC 0043-0483-06 D-755-2014

Class II · Moderate risk Terminated Jun 18, 2013

Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health NDC 0067-6318-06 D-754-2014

Class II · Moderate risk Terminated Jun 18, 2013

Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health NDC 0067-6427-06 D-753-2014

Class II · Moderate risk Terminated Jun 18, 2013

Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg)…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health NDC 0067-6426-06 D-752-2014

Class II · Moderate risk Terminated Jun 18, 2013

Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health NDC 0067-6319-06 D-751-2014

Class II · Moderate risk Terminated Jun 18, 2013

Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health D-750-2014

Class II · Moderate risk Terminated Jun 18, 2013

Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health NDC 0043-6257-06 D-749-2014

Class II · Moderate risk Terminated Jun 18, 2013

Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets…

Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health NDC 0067-7916-06 D-748-2014

Class II · Moderate risk Terminated Jun 6, 2013

Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count…

Reason Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health D-846-2013

Class II · Moderate risk Terminated Jun 6, 2013

Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches…

Reason Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health D-844-2013

Class II · Moderate risk Terminated Jun 6, 2013

Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes…

Reason Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health D-843-2013

Class III · Low risk Terminated May 15, 2013

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health…

Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Novartis Consumer Health NDC 0067-2062-02 D-744-2014

Class III · Low risk Terminated May 15, 2013

Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg…

Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Novartis Consumer Health NDC 0067-6437-08 D-743-2014

Class III · Low risk Terminated May 15, 2013

Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in…

Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Novartis Consumer Health NDC 0067-6438-08 D-742-2014

Class III · Low risk Terminated May 15, 2013

Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg…

Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Novartis Consumer Health NDC 0067-2081-24 D-741-2014

Class III · Low risk Terminated May 15, 2013

Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg…

Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Novartis Consumer Health NDC 0067-2084-24 D-740-2014

Class III · Low risk Terminated May 15, 2013

Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR…

Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Novartis Consumer Health NDC 0067-2081-24 D-739-2014

Class III · Low risk Terminated May 15, 2013

Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg…

Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Novartis Consumer Health NDC 0067-2082-32 D-738-2014

Class II · Moderate risk Terminated Apr 12, 2013

Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed…

Reason Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading…

Opmx, LLC D-299-2013