--- title: "Alembic Pharmaceuticals Limited Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Alembic Pharmaceuticals Limited recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/alembic-pharmaceuticals-limited/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Alembic Pharmaceuticals Limited recall records **5** reported ongoing 5 records in this archive. Latest source date Dec 16, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 16, 2025 FDA drug enforcement ### [Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: A...](https://isitonrecall.com/recall/fda-drug-d-0248-2026-fesoterodine-fumarate-extended-release-tablets-8-mg-30-tablets-rx-only-manufactured-by-alembic-pharm/) Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. Class III Reported ongoing Distribution: US Nationwide and PR. [Official source for Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alem...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0248-2026%22) Oct 10, 2025 FDA drug enforcement ### [Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured f...](https://isitonrecall.com/recall/fda-drug-d-0156-2026-fesoterodine-fumarate-extended-release-tablets-4-mg-30-count-bottle-rx-only-manufactured-by-alembic/) Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. Class III Reported ongoing Distribution: Nationwide in the USA. [Official source for Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by:...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0156-2026%22) Jul 25, 2025 FDA drug enforcement ### [Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic P...](https://isitonrecall.com/recall/fda-drug-d-0566-2025-doxepin-hydrochloride-capsules-usp-10-mg-100-capsules-rx-only-manufactured-by-alembic-pharmaceutical/) CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class II Reported ongoing Distribution: Nationwide in the USA. [Official source for Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharm...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0566-2025%22) May 9, 2025 FDA drug enforcement ### [Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for:...](https://isitonrecall.com/recall/fda-drug-d-0459-2025-celecoxib-capsules-200-mg-500-count-bottle-rx-only-manufactured-by-alembic-pharmaceuticals-limited-f/) Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule Class II Reported ongoing Distribution: Distributed Nationwide and in PR [Official source for Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals L...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0459-2025%22) May 7, 2025 FDA drug enforcement ### [Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmac...](https://isitonrecall.com/recall/fda-drug-d-0447-2025-bromfenac-ophthalmic-solution-0-09-1-7-ml-bottle-rx-only-sterile-manufactured-for-alembic-pharmaceut/) Failed Impurities/Degradation Specifications Class II Reported ongoing Distribution: US Nationwide [Official source for Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic P...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0447-2025%22) ## Reasons in these listed records - Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. - CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. - Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule - Failed Impurities/Degradation Specifications These examples come from this result page and are not a ranking of every recall reason. ## Checking Alembic Pharmaceuticals Limited ### Is there a recall on alembic pharmaceuticals limited right now? This archive contains 5 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Alembic Pharmaceuticals Limited](https://isitonrecall.com/check/?q=Alembic%20Pharmaceuticals%20Limited) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)