FDA recall record · openFDA

Denison Pharmaceuticals, LLC

8 FDA recalls on record (2023–2025) — 8 drug. 7 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

CGMP Deviations: Use of non-food grade lubricant in mixing vessel. 4

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottl 2

Chemical Contamination: Presence of benzene. 1

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. 1

Recalls

Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEA Class II 2025-02-24 Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medte Class II 2024-05-28 Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Inc Class II 2023-05-03 Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118 Class II 2023-05-03 Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Class II 2023-05-03 Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle Class II 2023-05-03 Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles fur Class III 2024-09-25 Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles furt Class III 2024-09-25

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

Machine-readable: JSON-LD · Markdown