Recall archive / FDA drug enforcement
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Mo... — FDA record D-0748-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc
- Quantity
- 20,112 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0748-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # TV11W101, Exp Mar 2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide in the USA and Puerto Rico
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 13, 2022
- Recall initiation date
- Apr 1, 2022
- Center classification date
- Apr 6, 2022
- Termination date
- Feb 27, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.