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Denison Pharmaceuticals Recalls
8 recalls on record · June 7, 2023 to March 19, 2025 · Drugs
Recalls by year
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 19, 2025DrugsFDA
Denison Pharmaceuticals, LLC recalls Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEA
Hazard: Chemical Contamination: Presence of benzene.
November 13, 2024DrugsFDA
Denison Pharmaceuticals, LLC recalls Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles furt
Hazard: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
November 13, 2024DrugsFDA
Denison Pharmaceuticals, LLC recalls Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles fur
Hazard: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
June 26, 2024DrugsFDA
Denison Pharmaceuticals, LLC recalls Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medte
Hazard: cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
June 7, 2023DrugsFDA
Denison Pharmaceuticals, LLC recalls Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118
Hazard: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
June 7, 2023DrugsFDA
Denison Pharmaceuticals, LLC recalls Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Inc
Hazard: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
June 7, 2023DrugsFDA
Denison Pharmaceuticals, LLC recalls Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota
Hazard: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
June 7, 2023DrugsFDA
Denison Pharmaceuticals, LLC recalls Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle
Hazard: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.