Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TUSSLIN (Dextromethorphan HBr Recalled by Pharma-Natural Inc. Due to CGMP Deviations: products were manufactured with lack of...
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 Pharma-Natural Inc. directly.
Affected Products
TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.
Quantity: 8340 bottles
Why Was This Recalled?
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pharma-Natural Inc.
Pharma-Natural Inc. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report