Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP Recalled by Qualitest Pharmaceuticals Due to Failed Impurities/Degradation Specifications: High out of specification results...
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 Qualitest Pharmaceuticals directly.
Affected Products
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Quantity: a) 3936 bottles; b) 84420 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Qualitest Pharmaceuticals
Qualitest Pharmaceuticals has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report