--- title: "Endo USA, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Endo USA, 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/endo-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Endo USA, Inc. recall records **11** reported ongoing 12 records in this archive. Latest source date Mar 13, 2026. 1 published notices do not supply a closure status. 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 13, 2026 FDA drug enforcement ### [Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.](https://isitonrecall.com/recall/fda-drug-d-0527-2026-buprenorphine-hydrochloride-injection-0-3mg-ml-5x1-ml-single-dose-vials-rx-only-manufactured-for-end/) Crystallization; identified as Buprenorphine free base Class II Reported ongoing Distribution: USA Nationwide [Official source for Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0527-2026%22) Oct 10, 2025 FDA drug enforcement ### [Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-...](https://isitonrecall.com/recall/fda-drug-d-0139-2026-everolimus-tablets-5mg-28-tablets-each-carton-contains-4-blister-strips-with-7-tablets-each-rx-only/) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Reported ongoing Distribution: Nationwide within the United States [Official source for Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), R...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0139-2026%22) Oct 10, 2025 FDA drug enforcement ### [Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 4988...](https://isitonrecall.com/recall/fda-drug-d-0140-2026-everolimus-tablets-7-5mg-28-tablets-each-carton-contains-4-blister-strips-with-7-tablets-each-rx-onl/) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Reported ongoing Distribution: Nationwide within the United States [Official source for Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each),...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0140-2026%22) Oct 10, 2025 FDA drug enforcement ### [Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 4988...](https://isitonrecall.com/recall/fda-drug-d-0141-2026-everolimus-tablets-10-mg-28-tablets-each-carton-contains-4-blister-strips-with-7-tablets-each-rx-onl/) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Reported ongoing Distribution: Nationwide within the United States [Official source for Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each),...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0141-2026%22) Oct 10, 2025 FDA drug enforcement ### [Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 498...](https://isitonrecall.com/recall/fda-drug-d-0142-2026-everolimus-tablets-2-5-mg-28-tablets-each-carton-contains-4-blister-strips-with-7-tablets-each-rx-on/) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Reported ongoing Distribution: Nationwide within the United States [Official source for Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each)...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0142-2026%22) Sep 5, 2025 FDA drug enforcement ### [Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-...](https://isitonrecall.com/recall/fda-drug-d-0026-2026-everolimus-tablets-5mg-28-tablets-each-carton-contains-4-blister-strips-with-7-tablets-each-rx-only/) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Reported ongoing Distribution: Nationwide within the United States [Official source for Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), R...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0026-2026%22) Dec 20, 2024 FDA drug enforcement ### [Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 420...](https://isitonrecall.com/recall/fda-drug-d-0223-2025-adrenalin-chloride-solution-epinephrine-nasal-solution-usp-30mg-30ml-1mg-ml-packaged-in-30-ml-vials/) Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP) Class I Reported ongoing Distribution: USA nationwide. [Official source for Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0223-2025%22) Nov 18, 2024 FDA drug enforcement ### [Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnu...](https://isitonrecall.com/recall/fda-drug-d-0178-2025-clonazepam-orally-disintegrating-tablet-usp-2-mg-c-iv-rx-only-60-tablets-per-carton-10-blister-cards/) Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blis...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0178-2025%22) Nov 18, 2024 FDA drug enforcement ### [Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, C...](https://isitonrecall.com/recall/fda-drug-d-0179-2025-clonazepam-orally-disintegrating-tablets-usp-0-125-mg-c-iv-rx-only-60-tablets-per-carton-10-blister/) Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0179-2025%22) Nov 18, 2024 FDA drug enforcement ### [Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Ch...](https://isitonrecall.com/recall/fda-drug-d-0180-2025-clonazepam-orally-disintegrating-tablets-usp-0-25-mg-c-iv-rx-only-60-tablets-per-carton-10-blister-c/) Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0180-2025%22) Nov 18, 2024 FDA drug enforcement ### [Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chest...](https://isitonrecall.com/recall/fda-drug-d-0181-2025-clonazepam-orally-disintegrating-tablets-usp-1-mg-c-iv-rx-only-60-tablets-per-carton-10-blister-card/) Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 bli...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0181-2025%22) Jul 17, 2024 FDA company announcement ### [Par Pharmaceutical: Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets](https://isitonrecall.com/recall/fdapress-de5cc875e995915a-par-pharmaceutical-clonazepam-orally-disintegrating-tablets-usp-c-iv-0-25-mg-tablets/) Mislabeled with the incorrect strength on the carton Not supplied Published notice; closure not supplied Distribution: The product lot was distributed through wholesale distributors to retail pharmacies nationwide. Endo is providing written notification to wholesale accounts and retailers that h... [Official source for Par Pharmaceutical: Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp) ## Reasons in these listed records - Crystallization; identified as Buprenorphine free base - Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. - Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP) - Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. These examples come from this result page and are not a ranking of every recall reason. ## Checking Endo USA, Inc. ### Is there a recall on endo usa, inc. right now? This archive contains 12 records, including 11 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 Endo USA, Inc.](https://isitonrecall.com/check/?q=Endo%20USA%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)