CLASS II Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report
Travoprost Ophthalmic Solution recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Travoprost Ophthalmic Solution, USP, 0.004%, distributed nationwide in the US. The recall was initiated on 1 Apr 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0748-2022
- FDA event ID
- 89906
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2022
- FDA classified
- 6 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 1 Apr 2022 | Recall initiated by company | |
| 6 Apr 2022 | Classified by FDA | +5 days |
| 13 Apr 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # TV11W101, Exp Mar 2023
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Travoprost recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Travoprost Ophthalmic Solution recalled by Golden State Medical SupplyTravoprost | Golden State Medical Supply | Sterility | Nationwide |
| Drug | CLASS II | Travoprost Ophthalmic Solution recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Travoprost Ophthalmic Solution USP, 0.004%, a) and b) recalled | Par Pharmaceutical | Sterility | Nationwide |