Zydus Pharmaceuticals recalls

Zydus Pharmaceuticals has 54 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 12 Aug 2026. 35 are still ongoing. 12 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls54since 2020

Last 12 months12reported

Class I24% of total

Ongoing35latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 1 0Jan '25 0 2 2Apr 2 1 0Jul 0 13 2Oct 4 0 2Jan '26 0 1 0Apr 2 0 0Jul 1 0

Severity split

Class I 2 4%Class II 43 80%Class III 9 17%

Why zydus pharmaceuticals is recalled

Product types

Brands

By year

2026611%
20252648%
2024917%
202359%
202212%
202136%
202047%

Ongoing zydus pharmaceuticals recalls

35 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 May 2026Drug	CLASS II	Erythromycin Tablets, USP, 250 mg recalledErythromycin	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 May 2026Drug	CLASS II	Erythromycin Tablets, USP, 500 mg recalledErythromycin	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Mar 2026Drug	CLASS II	Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl	Zydus Pharmaceuticals	Other	Nationwide
28 Jan 2026Drug	CLASS II	Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA)	Zydus Pharmaceuticals	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS III	traZODONE Hydrochloride Tablets, USP, 100mg recalledTrazodone Hydrochloride	Zydus Pharmaceuticals	Other	Nationwide

All zydus pharmaceuticals recalls, newest first

54 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 May 2026Drug	CLASS II	Erythromycin Tablets, USP, 250 mg recalledErythromycin	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 May 2026Drug	CLASS II	Erythromycin Tablets, USP, 500 mg recalledErythromycin	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Mar 2026Drug	CLASS II	Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl	Zydus Pharmaceuticals	Other	Nationwide
28 Jan 2026Drug	CLASS II	Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA)	Zydus Pharmaceuticals	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS III	traZODONE Hydrochloride Tablets, USP, 100mg recalledTrazodone Hydrochloride	Zydus Pharmaceuticals	Other	Nationwide
26 Nov 2025Drug	CLASS II	Bromocriptine Mesylate Capsules, USP, 5 mg recalledBromocriptine Mesylate	Zydus Pharmaceuticals	Potency & Assay	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
8 Oct 2025Drug	CLASS II	Entecavir Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals	Potency & Assay	Nationwide
8 Oct 2025Drug	CLASS II	Entecavir Tablets, USP, 0.5 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals	Potency & Assay	Nationwide
24 Sep 2025Drug	CLASS II	Entecavir Tablets, USP, 0.5 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals	Potency & Assay	Nationwide
24 Sep 2025Drug	CLASS II	Entecavir Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals (USA)Entecavir	Zydus Pharmaceuticals	Potency & Assay	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Succinylcholine Chloride Injection, USP 200 mg/ (20 mg/mL) recalledSuccinylcholine Chloride	Zydus Pharmaceuticals	Potency & Assay	4 states
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Jun 2025Drug	CLASS II	Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl	Zydus Pharmaceuticals	Packaging Defects	IL, MS, PA
28 May 2025Drug	CLASS II	Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium	Zydus Pharmaceuticals	Potency & Assay	Nationwide
28 May 2025Drug	CLASS II	Esomeprazole Magnesium for Delayed-Release Oral Suspension recalledEsomeprazole Magnesium	Zydus Pharmaceuticals	Potency & Assay	Nationwide
16 Apr 2025Drug	CLASS II	Venlafaxine Tablets, USP, 75 mg recalled by Zydus Pharmaceuticals (USA)Venlafaxine	Zydus Pharmaceuticals	Foreign Material	Nationwide
16 Apr 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP 10 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	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.