Hetero Labs Limited (Unit V) recalls

Hetero Labs Limited (Unit V) has 11 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 29 Apr 2026. 2 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls11since 2018

Last 12 months1reported

Class I19% of total

Ongoing2latest 29 Apr 2026

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 1Apr 0 0 0Jul 0 0

Severity split

Class I 1 9%Class II 10 91%Class III 0 0%

Why hetero labs limited (unit v) is recalled

Product types

Brands

By year

202619%
202019%
2018982%

Ongoing hetero labs limited (unit v) recalls

2 active

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Drug	CLASS II	Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium	Hetero Labs Limited (Unit V)	Other	Nationwide
3 Oct 2018Drug	CLASS I	Montelukast Sodium Tablets 10 mg recalled by Hetero Labs Limited Unit VMontelukast Sodium	Hetero Labs Limited Unit V	Packaging Defects	Nationwide

All hetero labs limited (unit v) recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Drug	CLASS II	Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium	Hetero Labs Limited (Unit V)	Other	Nationwide
2 Sep 2020Drug	CLASS II	Losartan Potassium Tablets USP, 50 mg recalled	Hetero Labs Limited (Unit V)	Other	Nationwide
3 Oct 2018Drug	CLASS I	Montelukast Sodium Tablets 10 mg recalled by Hetero Labs Limited Unit VMontelukast Sodium	Hetero Labs Limited Unit V	Packaging Defects	Nationwide
3 Oct 2018Drug	CLASS II	Montelukast Sodium Tablets, 10 mg* recalledMontelukast Sodium	Hetero Labs Limited Unit V	Other	Nationwide
29 Aug 2018Drug	CLASS II	Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg recalledValsartan	Hetero Labs Limited Unit V	Potency & Assay	Nationwide
29 Aug 2018Drug	CLASS II	Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg recalledValsartan	Hetero Labs Limited Unit V	Potency & Assay	Nationwide
29 Aug 2018Drug	CLASS II	Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg recalledValsartan	Hetero Labs Limited Unit V	Potency & Assay	Nationwide
29 Aug 2018Drug	CLASS II	Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg recalledValsartan	Hetero Labs Limited Unit V	Potency & Assay	Nationwide
21 Mar 2018Drug	CLASS II	Valganciclovir Tablets, USP, 450 mg recalledValganciclovir	Hetero Labs Limited Unit V	Temperature Abuse	Nationwide
21 Mar 2018Drug	CLASS II	Valacyclovir Tablets recalled by Hetero Labs Limited Unit VValacyclovir	Hetero Labs Limited Unit V	Temperature Abuse	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.