Denison Pharmaceuticals recalls
FDA enforcement reports naming Denison Pharmaceuticals, LLC as the recalling firm.
- Recall reports
- 8
- Class I (serious)
- 0
- Most recent report
- Mar 19, 2025
- Mar 19, 2025Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28Drug · Denison Pharmaceuticals, LLCChemical Contamination: Presence of benzene.Class II
- Nov 13, 2024Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400m…Drug · Denison Pharmaceuticals, LLCCrystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.Class III
- Nov 13, 2024Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 m…Drug · Denison Pharmaceuticals, LLCCrystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.Class III
- Jun 26, 2024Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 flDrug · Denison Pharmaceuticals, LLCcGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.Class II
- Jun 7, 2023Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP…Drug · Denison Pharmaceuticals, LLCCGMP Deviations: Use of non-food grade lubricant in mixing vessel.Class II
- Jun 7, 2023Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7Drug · Denison Pharmaceuticals, LLCCGMP Deviations: Use of non-food grade lubricant in mixing vessel.Class II
- Jun 7, 2023Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 FlDrug · Denison Pharmaceuticals, LLCCGMP Deviations: Use of non-food grade lubricant in mixing vessel.Class II
- Jun 7, 2023Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL)…Drug · Denison Pharmaceuticals, LLCCGMP Deviations: Use of non-food grade lubricant in mixing vessel.Class II