Denton Pharma recalls

Denton Pharma has 4 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 11 Nov 2020. 2 are still ongoing. The most frequent reason is nitrosamine impurity.

Total recalls4since 2020

Last 12 months0reported

Class I00% of total

Ongoing2latest 11 Nov 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 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 4 100%Class III 0 0%

Why denton pharma is recalled

Nitrosamine Impurity4100%

Product types

Diabetes Medication250%
Stomach & Acid Reflux Medication250%

By year

20204100%

Ongoing denton pharma recalls

2 active

Reported	Class	Recall	Company	Reason	Where
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP 750 mg recalled	Denton Pharma	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) recalled	Denton Pharma	Nitrosamine Impurity	Nationwide

All denton pharma recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP 750 mg recalled	Denton Pharma	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) recalled	Denton Pharma	Nitrosamine Impurity	Nationwide
29 Jan 2020Drug	CLASS II	Ranitidine Tablets, USP 300 mg a) recalled by Denton Pharma	Denton Pharma	Nitrosamine Impurity	Nationwide
29 Jan 2020Drug	CLASS II	Ranitidine Tablets, USP 150 mg , a) recalled by Denton Pharma	Denton Pharma	Nitrosamine Impurity	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.