Lower riskDrug recall · FDA · Published April 1, 2022
Mylan Travoprost Ophthalmic Solution Recall: Subpotent Drug Risk
Mylan recalls Travoprost Ophthalmic Solution 0.004% 2.5mL bottles due to subpotent drug levels and impurities. This may affect prescription eye drops for glaucoma treatment.
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.
“Mylan Travoprost Ophthalmic Solution Recall: Subpotent Drug Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35022-mylan-travoprost-ophthalmic-solution-recall-subpotent-drug-risk. Based on FDA recall #D-0748-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0748-2022%22&limit=1).
The FDA announced on April 1, 2022, that Mylan Pharmaceuticals Inc. voluntarily recalled Travoprost Ophthalmic Solution due to subpotent drug and failed impurity specifications. The recall affects 20,112 bottles distributed nationwide.
How to tell if you have it
Brand: Mylan
Product: Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only
NDC: 0378-9651-32
Lot #: TV11W101
Expiration: Mar 2023
The hazard
The product failed to meet assay and related substance impurity specifications during routine stability testing, resulting in subpotent drug levels and high out-of-specification results for degradation products.
Context
GovInfoNow's records show Mylan Pharmaceuticals Inc. has 54 other recalls on record since June 28, 2012. Recent Mylan recalls include Mycophenolate Mofetil Injections (Aug. 26, 2026), Prasugrel Tablets (Aug. 17, 2026), and Acamprosate Tablets (July 24, 2026). Other recent recalls of similar products include ImprimisRx Povidone Iodine Ophthalmic Solution (Aug. 24, 2026), Sun Pharmaceutical Fluocinolone Acetonide Solution (Dec. 30, 2025), and SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution (Nov. 26, 2025).
How to tell if you have this one
Check for the 2.5mL bottle labeled 'Travoprost Ophthalmic Solution, USP, 0.004%' with NDC 0378-9651-32. The lot number TV11W101 was manufactured in Morgantown, WV.
Brand
Mylan
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Medication Details
Identify the product by checking the bottle size, label, and NDC number.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0748-2022 (April 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0748-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.