--- title: "ALEMBIC PHARMACEUTICALS, INC. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search ALEMBIC PHARMACEUTICALS, INC. 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-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # ALEMBIC PHARMACEUTICALS, INC. recall records **3** reported ongoing 3 records in this archive. Latest source date Mar 18, 2026. 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 Mar 18, 2026 FDA drug enforcement ### [Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic ...](https://isitonrecall.com/recall/fda-drug-event-98647-e7266f8823a59267-bromfenac-ophthalmic-solution-0-07-3-ml-rx-only-sterile-manufactured-for-alembic-pharmaceuticals-inc/) Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceut...](https://api.fda.gov/drug/enforcement.json?search=event_id%3A%2298647%22) Jul 27, 2023 FDA drug enforcement ### [Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05](https://isitonrecall.com/recall/fda-drug-d-1086-2023-tobramycin-opthalmic-solution-usp-0-3-5ml-bottle-rx-only-manufactured-for-alembic-pharmaceuticals-be/) Failed Impurities/Degradation Specifications Class III Reported ongoing Distribution: Nationwide in the USA [Official source for Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceu...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1086-2023%22) Jun 22, 2023 FDA drug enforcement ### [Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by...](https://isitonrecall.com/recall/fda-drug-d-0941-2023-diclofenac-sodium-topical-solution-usp-2-w-w-3-8-fl-oz-112-grams-bottles-rx-only-manufactured-for-al/) Defective Delivery System Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactu...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0941-2023%22) ## Reasons in these listed records - Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing. - Failed Impurities/Degradation Specifications - Defective Delivery System These examples come from this result page and are not a ranking of every recall reason. ## Checking ALEMBIC PHARMACEUTICALS, INC. ### Is there a recall on alembic pharmaceuticals, inc. right now? This archive contains 3 records, including 3 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, INC.](https://isitonrecall.com/check/?q=ALEMBIC%20PHARMACEUTICALS%2C%20INC.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)