Denison Pharmaceuticals recalls

Denison Pharmaceuticals has 8 recalls on record with the FDA and USDA, the earliest in 2023 and the latest reported on 19 Mar 2025. 7 are still ongoing. The most frequent reason is manufacturing (cgmp) deviations.

Total recalls8since 2023

Last 12 months0reported

Class I00% of total

Ongoing7latest 19 Mar 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 2 0 0Jan '25 0 1 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 75%Class III 2 25%

Why denison pharmaceuticals is recalled

Product types

Brands

By year

2025113%
2024338%
2023450%

Ongoing denison pharmaceuticals recalls

7 active

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Drug	CLASS II	Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel recalledZapzyt Acne Treatment Gel	Denison Pharmaceuticals	Benzene	Nationwide
13 Nov 2024Drug	CLASS III	Kids' Cough and Chest Congestion (Dextromethorphan HBr recalledMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack	Denison Pharmaceuticals	Packaging Defects	RI
13 Nov 2024Drug	CLASS III	Adult Cough and Chest Congestion recalled by Denison PharmaceuticalsMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack	Denison Pharmaceuticals	Packaging Defects	RI
7 Jun 2023Drug	CLASS II	Safe tussin DM, DAY TIME Cough Relief recalled	Denison Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
7 Jun 2023Drug	CLASS II	Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine recalled	Denison Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
7 Jun 2023Drug	CLASS II	Safe tussin PM, Night Time Cough Relief recalled	Denison Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All denison pharmaceuticals recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Drug	CLASS II	Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel recalledZapzyt Acne Treatment Gel	Denison Pharmaceuticals	Benzene	Nationwide
13 Nov 2024Drug	CLASS III	Kids' Cough and Chest Congestion (Dextromethorphan HBr recalledMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack	Denison Pharmaceuticals	Packaging Defects	RI
13 Nov 2024Drug	CLASS III	Adult Cough and Chest Congestion recalled by Denison PharmaceuticalsMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack	Denison Pharmaceuticals	Packaging Defects	RI
26 Jun 2024Drug	CLASS II	Little Remedies Gas Relief Drops (Simethicone/Antigas) recalledLittle Remedies	Denison Pharmaceuticals	Sterility	RI
7 Jun 2023Drug	CLASS II	Safe tussin DM, DAY TIME Cough Relief recalled	Denison Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
7 Jun 2023Drug	CLASS II	Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine recalled	Denison Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
7 Jun 2023Drug	CLASS II	Safe tussin PM, Night Time Cough Relief recalled	Denison Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
7 Jun 2023Drug	CLASS II	Pin-Away Pyrental Pamoate (Pyrantel base 50 mg / mL) recalled	Denison Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.