Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Pain Relief & OTC Medication Recalls

Recalls of common over-the-counter and prescription pain relievers.

415 recalls in this category, newest first.

Class I · High risk

Enteric Coated Aspirin

Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.

Terminated Labeling / mix-up Advance Pharmaceutical Inc NDC 0536-3086-41 D-919-2013
Class II · Moderate risk

Parsel Plus

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

Terminated Packaging defect Novartis Consumer Health D-846-2013
Class II · Moderate risk

Excedrin Migraine

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

Terminated Packaging defect Novartis Consumer Health D-844-2013
Class II · Moderate risk

Excedrin Extra Strength

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

Terminated Packaging defect Novartis Consumer Health D-843-2013
Class II · Moderate risk

Naproxen 100 mg/ml Injection

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

Ongoing Sterility / contamination Lowlite Investments, Inc. D/B/A Olympia Pharmacy D-762-2013
Class II · Moderate risk

Meloxicam 5 mg/ml Injection

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

Ongoing Sterility / contamination Lowlite Investments, Inc. D/B/A Olympia Pharmacy D-752-2013
Class III · Low risk

Excedrin

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

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2062-02 D-744-2014
Class III · Low risk

Theraflu Warming Relief

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

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-6438-08 D-742-2014
Class III · Low risk

Maximum Strength Comtrex

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

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2081-24 D-741-2014
Class III · Low risk

Maximum Strength Comtrex

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

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2084-24 D-740-2014
Class II · Moderate risk

Pentrexcilina

Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.

Terminated Labeling / mix-up Opmx, LLC D-299-2013
Class III · Low risk

Glenmark Gabapentin Tablets

Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.

Terminated Chemical / undeclared Glenmark Generics Inc., USA NDC 68462-126-05 D-329-2013
Class II · Moderate risk

Children's Acetaminophen Oral Suspension

Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.

Terminated Labeling / mix-up Precision Dose Inc. NDC 68094-650-59 D-250-2013
Class III · Low risk

Voltaren Gel

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

Terminated Labeling / mix-up Novartis Consumer Health NDC 63481-684-83 D-577-2013
Class II · Moderate risk

traMADOL Hydrochloride Tablets

Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.

Terminated Particulate / foreign matter Caraco Pharmaceutical Laboratories, Ltd. NDC 57664-377-18 D-089-2013