Home / Recalls / MYLAN PHARMACEUTICALS INC / D-0399-2026

D-0399-2026 Class II Ongoing

Recalled by MYLAN PHARMACEUTICALS INC — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
March 11, 2026
Initiation Date
February 24, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34850 blister packs

Product Description

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 in France, NDC 0378-6614-93.

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 3116110, 3116130, Exp. Date 07/2026

Other recalls by MYLAN PHARMACEUTICALS INC

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  • D-1292-2022 Class I — Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL p (July 5, 2022)
  • D-0845-2022 Class I — Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packag (April 12, 2022)
  • D-0774-2022 Class II — Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufact (April 7, 2022)
  • D-0748-2022 Class II — Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufacture (April 1, 2022)
  • D-0452-2022 Class II — Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topica (January 21, 2022)
  • D-0462-2022 Class I — Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen ( (January 5, 2022)
  • D-0049-2021 Class III — Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packag (October 2, 2020)
  • D-1057-2020 Class III — Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals I (March 23, 2020)
  • D-1031-2020 Class II — Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceu (March 9, 2020)