Denison Pharmaceuticals, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 9
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0273-2025 | Class II | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by | February 24, 2025 |
| D-0034-2025 | Class III | Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged | September 25, 2024 |
| D-0033-2025 | Class III | Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged | September 25, 2024 |
| D-0557-2024 | Class II | Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dr | May 28, 2024 |
| D-0775-2023 | Class II | Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.12 | May 3, 2023 |
| D-0774-2023 | Class II | Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Dist | May 3, 2023 |
| D-0773-2023 | Class II | Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketom | May 3, 2023 |
| D-0772-2023 | Class II | Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 | May 3, 2023 |