Travoprost Ophthalmic Solution — Class II drug recall D-0748-2022
Terminated recall by Mylan Pharmaceuticals Inc, reported 2022-04-13, distributed nationwide. Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for
| Recall number | D-0748-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc, Morgantown, WV, United States |
| Recall initiated | 2022-04-01 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2023-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 20,112 bottles |
| Reason classes | potency, specification failure |
| NDC | 00378-9651, 00378-9651-32, 00378-9651-50 |
| Lot numbers | TV11W101 |
| Expiration dates | 2023-03-20 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0748-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.