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Denison Pharmaceuticals, LLC FDA Recalls
8 recalls on file across drugs, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEAClass IIFeb 24, 2025Chemical Contamination: Presence of benzene. |
| Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles furtClass IIISep 25, 2024Crystallization: Lack of uniformity - a change in texture, c |
| Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles furClass IIISep 25, 2024Crystallization: Lack of uniformity - a change in texture, c |
| Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by MedteClass IIMay 28, 2024cGMP deviations: Test results confirmed aypical Burkholderia |
| Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118Class IIMay 3, 2023CGMP Deviations: Use of non-food grade lubricant in mixing v |
| Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottleClass IIMay 3, 2023CGMP Deviations: Use of non-food grade lubricant in mixing v |
| Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 SarasotaClass IIMay 3, 2023CGMP Deviations: Use of non-food grade lubricant in mixing v |
| Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara IncClass IIMay 3, 2023CGMP Deviations: Use of non-food grade lubricant in mixing v |