Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PROMETHAZINE DM SYRUP (Promethazine Hydrochloride Recalled by Qualitest Pharmaceuticals Due to Presence of Foriegn Substance: Plastic cap closure particulates...
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
PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.
Quantity: 972 bottles
Why Was This Recalled?
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
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