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 II · Moderate risk

Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes

First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).

Terminated Other First Aid Only Inc D-1323-2014
Class III · Low risk

Advil PM Caplets

Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

Terminated Wrong potency / content Pfizer Us Pharmaceutical Group NDC 0573-0164-43 D-1166-2014
Class II · Moderate risk

Acetaminophen suspension liquid

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

Terminated Packaging defect L. Perrigo Co. NDC 49035-946-16 D-006-2014
Class II · Moderate risk

Acetaminophen suspension liquid

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

Terminated Packaging defect L. Perrigo Co. NDC 36800-766-16 D-005-2014
Class II · Moderate risk

Acetaminophen suspension liquid

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

Terminated Packaging defect L. Perrigo Co. NDC 37205-577-16 D-004-2014
Class II · Moderate risk

Acetaminophen suspension liquid

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

Terminated Packaging defect L. Perrigo Co. NDC 41163-590-16 D-003-2014
Class II · Moderate risk

Combo Eye Gel

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-414-2014
Class II · Moderate risk

Oxycodone and Acetaminophen Tablets

Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.

Terminated Particulate / foreign matter Watson Laboratories Inc NDC 0591-0825-01 D-66251-001
Class II · Moderate risk

Concentrated Motrin

Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed

Terminated Particulate / foreign matter Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. D-66272-001
Class III · Low risk

Hydrocodone Bitartrate and Acetaminophen Tablets

Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.

Terminated Packaging defect Watson Laboratories Inc NDC 0591-2611-05 D-1061-2013
Class II · Moderate risk

Vicks NyQuil Cold and Flu Nighttime Relief

Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.

Terminated Chemical / undeclared Procter & Gamble Co NDC 37000-807-12 D-1056-2013
Class II · Moderate risk

Ibu (NDC 55111-684-05)

Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

Terminated Labeling / mix-up Dr. Reddy's Laboratories, Inc. NDC 55111-684-05 D-1042-2013
Class II · Moderate risk

Children's Ibuprofen

CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.

Terminated Failed specification Central Shared Services dba Parallon D-1062-2014
Class II · Moderate risk

Acetaminophen Tablets

CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.

Terminated cGMP deviation Marlex Pharmaceuticals, Inc. NDC 10135-152-01 D-1064-2013
Class III · Low risk

Oxycodone and Acetaminophen Capsules

Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.

Terminated Wrong potency / content Watson Laboratories Inc NDC 0591-0737-01 D-823-2013
Class II · Moderate risk

DayQuil Sinex DayTime Sinus Relief

Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.

Terminated Labeling / mix-up Procter & Gamble Co D-827-2013
Class II · Moderate risk

Acetaminophen/ Butalbital/ Caffeine

Labeling: Label Mixup: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg may have potentially been mislabeled as the following drug: ASPIRIN, Tablet, 325 mg, NDC 49348000123, Pedigree: W002640, EXP: 6/4/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-982-2014
Class II · Moderate risk

Aspirin/Er Dipyridamole

Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been mislabeled as the following drug: THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD70639_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: W003439, EXP: 6/20/2014; ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: W003641, EXP: 6/25/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-980-2014
Class II · Moderate risk

Aspirin

Labeling: Label Mixup: ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 0 mg, NDC 42865010302, Pedigree: W003354, EXP: 6/19/2014; acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: W003524, EXP: 6/21/2014; METOPROLOL TARTRATE, Tablet, 25 mg, NDC 00378001801, Pedigree: W002535, EXP: 6/3/2014; RIVAROXABAN, Tablet, 20 mg,

Terminated Labeling / mix-up Aidapak Services, LLC D-928-2014
Class II · Moderate risk

Aspirin

Labeling: Label Mixup: ASPIRIN, CHEW Tablet, 81 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD30028_4, EXP: 5/8/2014; MODAFINIL, Tablet, 200 mg, NDC 00603466216, Pedigree: W002760, EXP: 6/6/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W003015, EXP: 6/12/2014; VITAMIN B COMPLEX

Terminated Labeling / mix-up Aidapak Services, LLC D-927-2014