Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Aspirin recalled?

Yes — there is an active recall. 4 ongoing FDA recalls mention Aspirin (59 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Aspirin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Aspirin recalls on record

none so far in 2026; 59 on record, newest first
Class III · Low risk

Vica-Cet BACK PAIN RELIEF

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

Terminated Stability / shelf life Ultra Seal Corporation D-0071-2022
Class III · Low risk

PainAway II

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

Terminated Stability / shelf life Ultra Seal Corporation D-0070-2022
Class I · High risk

Acetaminophen

Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.

Terminated Labeling / mix-up A-S Medication Solutions LLC. D-0358-2021
Class III · Low risk

Extra Strength Headache Relief

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

Terminated Stability / shelf life Ultra Seal Corporation D-1513-2020
Class III · Low risk

Pain Relief Maximum Strength

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

Terminated Stability / shelf life Ultra Seal Corporation D-1512-2020
Class III · Low risk

Smart Sense Regular Strength Aspirin Tablets

Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.

Terminated Stability / shelf life AAA Pharmaceutical, Inc. D-1585-2019
Class II · Moderate risk

Pain & Fever Oral Solution

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

Terminated Microbial contamination Torrent Pharma Inc D-1366-2019
Class II · Moderate risk

RPC Children's Non-Aspirin

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Terminated Microbial contamination RIJ Pharmaceutical LLC NDC 53807-129-04 D-0845-2018
Class II · Moderate risk

Alka-Seltzer Extra Strength

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

Terminated Packaging defect Bayer HealthCare Pharmaceuticals, Inc. D-1050-2017
Class II · Moderate risk

Alka-Seltzer Original

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

Terminated Packaging defect Bayer HealthCare Pharmaceuticals, Inc. D-1044-2017
Class III · Low risk

SKY Aspirin Chewable Tablets

Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.

Terminated Labeling / mix-up Mckesson Packaging Services NDC 63739-434-01 D-0834-2016
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
Class II · Moderate risk

Aspirin Dr Ec

Labeling: Label Mixup: ASPIRIN DR EC, Tablet, 81 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 120 mg, NDC 00093106001, Pedigree: AD49448_20, EXP: 5/17/2014; FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: W003097, EXP: 6/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-875-2014
Class II · Moderate risk

ASPIRIN EC DR Tablet

Labeling: Label Mixup; ASPIRIN EC DR Tablet, 81 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD28322_7, EXP: 5/6/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W003671, EXP: 6/25/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-585-2014