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Is Caffeine recalled?

51 FDA recalls mention Caffeine. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Caffeine.

Class II · Moderate risk Ongoing Oct 17, 2025

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB…

Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…

Aero Healthcare NDC 55305-135-01 D-0155-2026

Class I · High risk Ongoing Jul 11, 2024

Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by…

Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

Aurobindo Pharma USA Inc NDC 58602-882-21 D-0641-2024

Class II · Moderate risk Terminated Jan 26, 2022

DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc…

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-941-00 D-0554-2022

Class II · Moderate risk Terminated Jan 26, 2022

Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab…

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-800-00 D-0553-2022

Class II · Moderate risk Terminated Jan 26, 2022

Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-565-00 D-0547-2022

Class II · Moderate risk Terminated Jan 26, 2022

HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories…

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62969-242-00 D-0538-2022

Class II · Moderate risk Terminated Jan 24, 2022

Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets…

Reason cGMP deviations

Ultra Seal Corporation D-0507-2022

Class II · Moderate risk Terminated Jan 24, 2022

PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD…

Reason cGMP deviations

Ultra Seal Corporation D-0504-2022

Class II · Moderate risk Terminated Jan 24, 2022

PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD…

Reason cGMP deviations

Ultra Seal Corporation D-0503-2022

Class II · Moderate risk Terminated Jan 24, 2022

PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD…

Reason cGMP deviations

Ultra Seal Corporation D-0502-2022

Class II · Moderate risk Terminated Jan 24, 2022

PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer…

Reason cGMP deviations

Ultra Seal Corporation D-0501-2022

Class II · Moderate risk Terminated Jan 24, 2022

Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets…

Reason cGMP deviations

Ultra Seal Corporation NDC 67060-0113-00 D-0498-2022

Class II · Moderate risk Terminated Jan 24, 2022

PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by…

Reason cGMP deviations

Ultra Seal Corporation NDC 42961-0003-00 D-0493-2022

Class II · Moderate risk Terminated Jan 24, 2022

PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical…

Reason cGMP deviations

Ultra Seal Corporation D-0492-2022

Class II · Moderate risk Terminated Jan 24, 2022

PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet…

Reason cGMP deviations

Ultra Seal Corporation D-0488-2022

Class II · Moderate risk Terminated Jan 24, 2022

Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2…

Reason cGMP deviations

Ultra Seal Corporation D-0485-2022

Class II · Moderate risk Terminated Jan 24, 2022

Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet…

Reason cGMP deviations

Ultra Seal Corporation NDC 42961-111-83 D-0482-2022

Class II · Moderate risk Terminated Jan 24, 2022

Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL…

Reason cGMP deviations

Ultra Seal Corporation NDC 47682-073-00 D-0476-2022

Class II · Moderate risk Terminated Jan 24, 2022

DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c)…

Reason cGMP deviations

Ultra Seal Corporation D-0472-2022

Class II · Moderate risk Terminated Dec 6, 2021

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet…

Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing…

Medique Products D-0391-2022

Class II · Moderate risk Terminated Dec 6, 2021

Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit…

Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing…

Medique Products D-0390-2022

Class II · Moderate risk Terminated Dec 6, 2021

Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as…

Reason CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing…

Medique Products D-0389-2022

Class II · Moderate risk Terminated Nov 29, 2021

PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes…

Reason CGMP Deviations: failed stability results, inadequate laboratory investigations,

ULTRAtab Laboratories, Inc. NDC 62959-560-00 D-0327-2022

Class III · Low risk Terminated Oct 13, 2021

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package…

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

Ultra Seal Corporation D-0077-2022

Class III · Low risk Terminated Oct 13, 2021

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package…

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

Ultra Seal Corporation D-0076-2022