Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension Recalled by Tris Pharma Inc. Due to Superpotent Drug and Failed Stability Specifications: High out-of-specification...
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 Tris Pharma Inc. directly.
Affected Products
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.
Quantity: 2,550 bottles
Why Was This Recalled?
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tris Pharma Inc.
Tris Pharma Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report