Yes — there is an active recall. 2 ongoing FDA recalls mention Caffeine (51 total). Check the affected lots below.
Most common reason: cGMP deviation (22 of these recalls)
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.
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
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