Promethazine Dm Syrup
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Yes — there is an active recall. 119 ongoing FDA recalls mention Alcohol (464 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alcohol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Lack of sterility assurance.
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Microbial Contamination of Non-Sterile Product
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
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