--- title: "Lannett Company, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Lannett Company, 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/lannett-company-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Lannett Company, Inc. recall records **4** reported ongoing 10 records in this archive. Latest source date Jun 26, 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 Jun 26, 2026 FDA drug enforcement ### [Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distri...](https://isitonrecall.com/recall/fda-drug-d-0660-2026-dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-ampheta/) Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. Class II Reported ongoing Distribution: US Nationwide. [Official source for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Am...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0660-2026%22) May 27, 2026 FDA drug enforcement ### [Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.](https://isitonrecall.com/recall/fda-drug-d-0584-2026-niacin-extended-release-tablets-usp-1-000-mg-90-count-bottles-rx-only-distributed-by-lannett-company/) Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannet...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0584-2026%22) Apr 24, 2026 FDA drug enforcement ### [Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.](https://isitonrecall.com/recall/fda-drug-d-0533-2026-primidone-tablets-usp-250mg-100-count-bottle-rx-only-distributed-by-lannett-company-inc-philadelphia/) Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Reported ongoing Distribution: USA Nationwide [Official source for Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., P...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0533-2026%22) Oct 10, 2025 FDA drug enforcement ### [Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46](https://isitonrecall.com/recall/fda-drug-d-0096-2026-niacin-extended-release-tablets-usp-1-000-mg-rx-only-90-tablets-per-bottle-distributed-by-lannett-co/) Failed Dissolution Specifications Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: L...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0096-2026%22) Aug 19, 2025 FDA drug enforcement ### [Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Co...](https://isitonrecall.com/recall/fda-drug-d-0642-2025-dextroamphetamine-saccharate-amphetamine-aspartate-dextroamphetamine-sulfate-and-amphetamine-sulfate/) Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine... Class II Reported completed Distribution: OH [Official source for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Su...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0642-2025%22) Aug 11, 2025 FDA drug enforcement ### [Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37](https://isitonrecall.com/recall/fda-drug-d-0599-2025-lisdexamfetamine-dimesylate-capsules-40-mg-100-count-bottles-rx-only-distributed-by-lannett-company/) Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. Class II Reported terminated Distribution: Nationwide within the USA [Official source for Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0599-2025%22) Oct 25, 2024 FDA drug enforcement ### [Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37](https://isitonrecall.com/recall/fda-drug-d-0112-2025-lisdexamfetamine-dimesylate-capsules-10-mg-100-capsules-per-bottle-rx-only-distributed-by-lannet-com/) Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. Class II Reported terminated Distribution: Nationwide in the USA [Official source for Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: La...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0112-2025%22) Nov 9, 2022 FDA drug enforcement ### [Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-16...](https://isitonrecall.com/recall/fda-drug-d-0160-2023-triamterene-and-hydrochlorothiazide-capsules-usp-37-5-mg-25-mg-rx-only-1000-capsules-per-bottle-dist/) Failed Impurity/Degradation Specifications Class III Reported terminated Distribution: Nationwide USA [Official source for Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bot...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0160-2023%22) Nov 9, 2022 FDA drug enforcement ### [Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, (100 or 1000 ) Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. ND...](https://isitonrecall.com/recall/fda-drug-d-0161-2023-triamterene-and-hydrochlorothiazide-capsules-usp-37-5-mg-25-mg-rx-only-100-or-1000-capsules-per-bott/) Failed Impurity/Degradation Specifications Class III Reported terminated Distribution: Nationwide USA [Official source for Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, (100 or 1000 ) Capsul...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0161-2023%22) Feb 9, 2022 FDA drug enforcement ### [Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.](https://isitonrecall.com/recall/fda-drug-d-0558-2022-diazepam-oral-solution-concentrate-25-mg-per-5-ml-5-mg-ml-30-ml-bottle-and-dropper-rx-only-distribut/) Failed Impurities/Degradation Specifications: Out of specification results for related substances. Class II Reported terminated Distribution: Product was distributed nationwide in the USA. [Official source for Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0558-2022%22) ## Reasons in these listed records - Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. - Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. - Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Failed Dissolution Specifications These examples come from this result page and are not a ranking of every recall reason. ## Checking Lannett Company, Inc. ### Is there a recall on lannett company, inc. right now? This archive contains 10 records, including 4 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 Lannett Company, Inc.](https://isitonrecall.com/check/?q=Lannett%20Company%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)