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Mylan Pharmaceuticals Inc.

FDA Regulatory Profile

Mylan Pharmaceuticals Inc. has 84 FDA recalls (3 Class I), 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Mylan Pharmaceuticals Inc." and its spelling variant "Mylan Pharmaceuticals". Records filed under related names are not included; see Related names.

Latest recall
D-0830-2026 · Class II · Aug 26, 2026
Latest inspection
Sep 22, 2020 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls84 (3 Class I)Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Mylan Pharmaceuticals Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Mylan Pharmaceuticals Inc.: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 0 inspections020192020: 1 inspections120202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600050
202500010
202400000
202300000
202200063
202100000
202010050
201900060
2018000230
2017000100

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

84 recall records from Jun 28, 2012 to Aug 26, 2026. Showing the 20 most recent. View all 84 recall records

NumberClassProductDate
D-0830-2026Class IICarton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials…Aug 26, 2026
D-0839-2026Class IIPrasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan…Aug 17, 2026
D-0774-2026Class IIAcamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan…Jul 24, 2026
D-0734-2026Class IIMycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only…Jul 2, 2026
D-0399-2026Class IIAmnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only…Feb 24, 2026
D-0280-2025Class IIPrasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals…Feb 25, 2025
D-1292-2022Class IInsulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC…Jul 5, 2022
D-0845-2022Class IInsulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL…Apr 12, 2022
D-0774-2022Class IIRifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan…Apr 7, 2022
D-0748-2022Class IITravoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan…Apr 1, 2022
D-0452-2022Class IIProctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g…Jan 21, 2022
D-0462-2022Class ISemglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71)…Jan 5, 2022
D-0049-2021Class IIICandesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count…Oct 2, 2020
D-1057-2020Class IIITacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV…Mar 23, 2020
D-1031-2020Class IISotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc…Mar 9, 2020
D-0792-2020Class IINizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.Jan 7, 2020
D-0791-2020Class IINizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.Jan 7, 2020
D-0186-2020Class IIAlprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals…Oct 23, 2019
D-0155-2020Class IIPrasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc…Oct 18, 2019
D-1848-2019Class IIIGatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals…Sep 6, 2019

Recent FDA inspections

6 inspections from Sep 27, 2012 to Sep 22, 2020.

DateSiteProductClassificationFEI
Sep 22, 2020San Carlos, CADrugsNo Action Indicated (NAI)3007886374
Oct 14, 2016San Carlos, CADevicesNo Action Indicated (NAI)3007886374
Jul 17, 2015San Carlos, CADrugsVoluntary Action Indicated (VAI)3007886374
Sep 4, 2014San Carlos, CADrugsNo Action Indicated (NAI)3007886374
Apr 16, 2014Greensboro, NCDrugsNo Action Indicated (NAI)1051627
Sep 27, 2012San Carlos, CADrugsNo Action Indicated (NAI)3007886374
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3007886374San Carlos, CA5Sep 22, 2020
FEI 1051627Greensboro, NC1Apr 16, 2014

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.