Hetero USA recalls

Hetero USA has 4 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 19 Apr 2023. 1 is still ongoing. The most frequent reason is manufacturing (cgmp) deviations.

Total recalls4since 2017

Last 12 months0reported

Class I00% of total

Ongoing1latest 19 Apr 2023

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 2 50%Class III 2 50%

Why hetero usa is recalled

Product types

Brands

By year

2023125%
2017375%

Ongoing hetero usa recalls

1 active

Reported	Class	Recall	Company	Reason	Where
19 Apr 2023Drug	CLASS II	Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium	Hetero USA	Manufacturing (CGMP) Deviations	Nationwide

All hetero usa recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
19 Apr 2023Drug	CLASS II	Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium	Hetero USA	Manufacturing (CGMP) Deviations	Nationwide
23 Aug 2017Drug	CLASS II	Entecavir Tablets 5 mg per container recalled by Hetero USAEntecavir	Hetero USA	Potency & Assay	NJ
14 Jun 2017Drug	CLASS III	Acyclovir Tablets, USP, 800 mg recalled by Hetero USAAcyclovir	Hetero USA	Other	Nationwide
5 Apr 2017Drug	CLASS III	Montelukast sodium tablets, 10 mg recalled by Hetero USAMontelukast Sodium	Hetero USA	Packaging Defects	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.