Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Safe tussin DM Recalled by Denison Pharmaceuticals, LLC Due to CGMP Deviations: Use of non-food grade lubricant in...
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 Denison Pharmaceuticals, LLC directly.
Affected Products
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Quantity: 86,616 4 OZ bottles
Why Was This Recalled?
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Denison Pharmaceuticals, LLC
Denison Pharmaceuticals, LLC 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