Alembic Pharmaceuticals recalls

Alembic Pharmaceuticals has 9 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 14 Jan 2026. 7 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls9since 2020

Last 12 months2reported

Class I111% of total

Ongoing7latest 14 Jan 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 1 11%Class II 5 56%Class III 3 33%

Why alembic pharmaceuticals is recalled

Product types

Brands

By year

2026111%
2025444%
2023222%
2021111%
2020111%

Ongoing alembic pharmaceuticals recalls

7 active

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Drug	CLASS III	Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate	Alembic Pharmaceuticals	Potency & Assay	Nationwide
26 Nov 2025Drug	CLASS III	Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate	Alembic Pharmaceuticals	Potency & Assay	Nationwide
13 Aug 2025Drug	CLASS II	Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride	Alembic Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Jun 2025Drug	CLASS II	Celecoxib Capsules, 200 mg recalled by Alembic PharmaceuticalsCelecoxib	Alembic Pharmaceuticals	Hidden Drug Ingredients	Nationwide
4 Jun 2025Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09%	Alembic Pharmaceuticals	Sterility	Nationwide
23 Aug 2023Drug	CLASS III	Tobramycin Opthalmic Solution recalled by Alembic PharmaceuticalsTobramycin Ophthalmic Solution	Alembic Pharmaceuticals	Potency & Assay	Nationwide

All alembic pharmaceuticals recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Drug	CLASS III	Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate	Alembic Pharmaceuticals	Potency & Assay	Nationwide
26 Nov 2025Drug	CLASS III	Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate	Alembic Pharmaceuticals	Potency & Assay	Nationwide
13 Aug 2025Drug	CLASS II	Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride	Alembic Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Jun 2025Drug	CLASS II	Celecoxib Capsules, 200 mg recalled by Alembic PharmaceuticalsCelecoxib	Alembic Pharmaceuticals	Hidden Drug Ingredients	Nationwide
4 Jun 2025Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09%	Alembic Pharmaceuticals	Sterility	Nationwide
23 Aug 2023Drug	CLASS III	Tobramycin Opthalmic Solution recalled by Alembic PharmaceuticalsTobramycin Ophthalmic Solution	Alembic Pharmaceuticals	Potency & Assay	Nationwide
2 Aug 2023Drug	CLASS II	Diclofenac Sodium Topical Solution USP, 2% w/w recalledDiclofenac Sodium	Alembic Pharmaceuticals	Other	Nationwide
14 Apr 2021Drug	CLASS I	Telmisartan Tablets, USP 20 mg recalled by Alembic PharmaceuticalsTelmisartan	Alembic Pharmaceuticals	Packaging Defects	Nationwide
1 Jul 2020Drug	CLASS II	Aripiprazole Tablets, USP, 2 mg recalled by Alembic PharmaceuticalsAripiprazole	Alembic Pharmaceuticals	Other	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.