Skip to content

Is Phenylephrine recalled?

292 FDA recalls mention Phenylephrine. The most recent are listed below.

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

Class II · Moderate risk Terminated Aug 26, 2013

Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park…

Reason Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory…

Leiter's Pharmacy D-1041-2013

Class II · Moderate risk Terminated Jul 3, 2013

DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus…

Reason Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly…

Procter & Gamble Co D-827-2013

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

Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder…

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

Novartis Consumer Health D-762-2014

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 DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg)…

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

Novartis Consumer Health D-760-2014

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

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 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 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 Ongoing May 29, 2013

Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lowlite Investments, Inc. D/B/A Olympia Pharmacy D-772-2013

Class II · Moderate risk Terminated May 28, 2013

Lidocaine 4%/Phenylephrine 1% 5, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…

Main Street Family Pharmacy, LLC D-164-2014

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

Class II · Moderate risk Terminated Apr 10, 2013

Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850…

Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…

FVS Holdings, Inc. dba. Green Valley Drugs D-398-2013