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

Yes — there is an active recall. 2 ongoing FDA recalls mention Caffeine (51 total). Check the affected lots below.

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

Caffeine recalls on record

none so far in 2026; 51 on record, newest first
Class III · Low risk

AERO Tab PAIN RELIEVER

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

Terminated Stability / shelf life Ultra Seal Corporation D-0073-2022
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 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 II · Moderate risk

Caffeine Powder

Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.

Terminated Unapproved drug Global Marketing Enterprises, Inc. D-1096-2017
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

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

CAFFEINE Tablet

Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260, Pedigree: AD21846_24, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD60240_4, EXP: 5/22/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: W003020, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, ND

Terminated Labeling / mix-up Aidapak Services, LLC D-540-2014
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

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

No Doz

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

Terminated Packaging defect Novartis Consumer Health D-845-2013
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
Class III · Low risk

Midol Complete

Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

Terminated Labeling / mix-up Bayer Healthcare, LLC NDC 0280-8005-16 D-1424-2012