--- title: "Mylan Pharmaceuticals Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Mylan 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/mylan-pharmaceuticals-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Mylan Pharmaceuticals Inc recall records **6** reported ongoing 12 records in this archive. Latest source date Aug 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 Aug 26, 2026 FDA drug enforcement ### [Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made...](https://isitonrecall.com/recall/fda-drug-d-0830-2026-carton-label-mycophenolate-mofetil-for-injection-usp-500-mg-vial-sterile-4-single-dose-vials-rx-only/) Failed Dissolution Specifications Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0830-2026%22) Aug 17, 2026 FDA drug enforcement ### [Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.](https://isitonrecall.com/recall/fda-drug-d-0839-2026-prasugrel-tablets-usp-10mg-rx-only-30-tablets-in-each-bottle-manufactured-for-mylan-pharmaceuticals/) Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmac...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0839-2026%22) Jul 24, 2026 FDA drug enforcement ### [Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 2665...](https://isitonrecall.com/recall/fda-drug-d-0774-2026-acamprosate-calcium-delayed-release-tablets-333-mg-180-tablets-bottles-rx-only-mylan-pharmaceuticals/) Failed Dissolution Specifications Class II Reported ongoing Distribution: US Nationwide. [Official source for Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmac...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0774-2026%22) Jul 2, 2026 FDA drug enforcement ### [Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made i...](https://isitonrecall.com/recall/fda-drug-d-0734-2026-mycophenolate-mofetil-for-injection-usp-500-mg-vial-single-dose-vial-4-vials-per-carton-rx-only-manu/) Presence of precipitate Class II Reported ongoing Distribution: USA Nationwide [Official source for Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx on...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0734-2026%22) Feb 24, 2026 FDA drug enforcement ### [Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made...](https://isitonrecall.com/recall/fda-drug-d-0399-2026-amnesteem-isotretinoin-capsules-usp-40-mg-packaged-in-3-x-10-count-prescription-packs-rx-only-manufa/) Failed Dissolution Specifications Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Onl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0399-2026%22) Feb 25, 2025 FDA drug enforcement ### [Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93](https://isitonrecall.com/recall/fda-drug-d-0280-2025-prasugrel-tablets-usp-5-mg-30-count-bottle-rx-only-manufactured-for-mylan-pharmaceuticals-inc-morgan/) Failed Dissolution Specifications - low dissolution results Class II Reported ongoing Distribution: US Nationwide. [Official source for Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals I...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0280-2025%22) Jul 5, 2022 FDA drug enforcement ### [Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx ...](https://isitonrecall.com/recall/fda-drug-d-1292-2022-insulin-glargine-insulin-glargine-yfgn-injection-100-units-ml-u-100-3-ml-prefilled-pens-ndc-49502-39/) Labeling: Missing label: Label missing from some prefilled pens. Class I Reported terminated Distribution: Product was distributed nationwide within the United States [Official source for Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (ND...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1292-2022%22) Apr 12, 2022 FDA drug enforcement ### [Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals...](https://isitonrecall.com/recall/fda-drug-d-0845-2022-insulin-glargine-insulin-glargine-yfgn-injection-100-units-ml-u-100-packaged-in-a-10-ml-multiple-dos/) Labeling: Missing label on the vial Class I Reported terminated Distribution: USA nationwide. [Official source for Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Mul...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0845-2022%22) Apr 7, 2022 FDA drug enforcement ### [Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60](https://isitonrecall.com/recall/fda-drug-d-0774-2022-rifampin-for-injection-usp-600-mg-vial-one-vial-per-carton-rx-only-manufactured-for-mylan-institutio/) Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing. Class II Reported terminated Distribution: Nationwide in the USA [Official source for Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan I...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0774-2022%22) Apr 1, 2022 FDA drug enforcement ### [Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.](https://isitonrecall.com/recall/fda-drug-d-0748-2022-travoprost-ophthalmic-solution-usp-0-004-2-5-ml-bottle-rx-only-manufactured-for-mylan-pharmaceutical/) Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing. Class II Reported terminated Distribution: Nationwide in the USA and Puerto Rico [Official source for Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Phar...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0748-2022%22) Jan 21, 2022 FDA drug enforcement ### [Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, Ne...](https://isitonrecall.com/recall/fda-drug-d-0452-2022-proctofoam-hc-hydrocortisone-acetate-1-and-pramoxine-hydrochloride-1-topical-aerosol-10-g-aerosol-co/) cGMP deficiencies Class II Reported terminated Distribution: Recalled product was distributed nationwide within the United States. [Official source for Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g ae...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0452-2022%22) Jan 5, 2022 FDA drug enforcement ### [Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only,...](https://isitonrecall.com/recall/fda-drug-d-0462-2022-semglee-insulin-glargine-injection-100-units-ml-u-100-3-ml-prefilled-pen-ndc-49502-0196-71-packaged/) Labeling: Missing Label: label missing from some Semglee prefilled pens. Class I Reported terminated Distribution: Nationwide in the USA and Thailand. [Official source for Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0462-2022%22) ## Reasons in these listed records - Failed Dissolution Specifications - Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria - Presence of precipitate - Failed Dissolution Specifications - low dissolution results These examples come from this result page and are not a ranking of every recall reason. ## Checking Mylan Pharmaceuticals Inc ### Is there a recall on mylan pharmaceuticals inc right now? This archive contains 12 records, including 6 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 Mylan Pharmaceuticals Inc](https://isitonrecall.com/check/?q=Mylan%20Pharmaceuticals%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)