Mylan Pharmaceuticals recall: Carton label: Mycophenolate Mofetil for injection
Mylan Pharmaceuticals Inc is recalling Carton label: Mycophenolate Mofetil for injection – 11,336 units. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 26, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Carton label: Mycophenolate Mofetil for injection |
| Brand | Mylan Pharmaceuticals |
| Company | Mylan Pharmaceuticals Inc |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 26, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | 11,336 units |
| Recall ID | 99750 |
Recalled products
- 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 in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.
- FDA recall number
- D-0830-2026
- Codes, lots and dates
- Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
- Quantity
- 11,336 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99750
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Morgantown, WV, United States
Why it was recalled
The reason the FDA lists: “Failed Dissolution Specifications”
Where it was sold
Nationwide. Distribution as the FDA records it: “U.S. Nationwide”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99750, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Mylan Pharmaceuticals recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 9, 2026 |  Mylan Pharmaceuticals recall: Prasugrel TabletsDrugs · 47,662 bottles | Failed Dissolution Specifications; product failed to meet 18-month stability testing accep… Serious | FDA Class II |
| Aug 26, 2026 | Mylan Pharmaceuticals recall: Acamprosate CalciumDrugs | Failed Dissolution Specifications Serious | FDA Class II |
All 3 Mylan Pharmaceuticals recalls →
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Mylan Pharmaceuticals Carton label: Mycophenolate Mofetil for injection recalled?
Yes. Mylan Pharmaceuticals Inc recalled it on August 26, 2026; FDA published it September 9, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed Dissolution Specifications
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.