Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medique Pain-Off (Acetaminophen 250 mg Recalled by Medique Products Due to CGMP Deviations: manufacturer recalled after an FDA inspection...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medique Products directly.
Affected Products
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967.
Quantity: 16,630,118 tablets
Why Was This Recalled?
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medique Products
Medique Products has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report