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 II · Moderate risk

ASPIRIN Tablet

Labeling: Label Mixup; ASPIRIN Tablet, 325 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002642, EXP: 6/4/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-582-2014
Class II · Moderate risk

Acetaminophen/ Aspirin/ Caffeine

Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: W003714, EXP: 6/26/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-572-2014
Class II · Moderate risk

Acetaminophen/ Aspirin/ Caffeine

Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD68025_8, EXP: 5/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-476-2014
Class II · Moderate risk

Tri-Buffered Aspirin

Labeling: Label Mixup: TRI-BUFFERED ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as the following drug: ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: W003596, EXP: 5/31/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-1026-2014
Class II · Moderate risk

Aspirin Ec

Labeling: Label Mixup: ASPIRIN EC, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0 mg, NDC 58914001460, Pedigree: AD30180_10, EXP: 5/9/2014; DILTIAZEM HCL ER, Capsule, 240 mg, NDC 49884083109, Pedigree: AD52375_1, EXP: 5/17/2014; ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W003355, EXP: 6/19/2014; ASPIRIN, Tab

Terminated Labeling / mix-up Aidapak Services, LLC D-1025-2014
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

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

Walgreens ASPIRIN FREE TENSION HEADACHE

Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.

Terminated Chemical / undeclared LNK International, Inc. NDC 0363-0428-12 D-0319-2015