Par Pharmaceutical Recalls Travoprost Ophthalmic Solution Due to Sterility Concerns
Par Pharmaceutical is recalling specific lots of Travoprost Ophthalmic Solution because the dropper tips may be damaged, compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility in an ophthalmic product) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Par Pharmaceutical, Inc. is recalling specific lots of Travoprost Ophthalmic Solution USP, 0.004%, in 2.5 mL and 5 mL bottles. The recall is due to damage to the internal portion of the dropper tip, which creates a lack of assurance of sterility for the product.
The affected product is distributed nationwide. The specific lot numbers and expiration dates are listed in the recall details. The product is prescription-only and intended for use in the eyes only.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977
- Manufacturer
- Par Pharmaceutical, Inc.
- Category
- Drug — Ophthalmic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- a) G40814 - Exp. Date 09/2016
- GA50089 - Exp. Date 12/2016
- GA50259 - Exp. Date 01/2017
- GA50657 - Exp. Date 03/2017
- GA51073 - Exp. Date 06/2017
- GA51651 - Exp. Date 09/2017
- GA51652 - Exp. Date 09/2017
- GA51722 - Exp. Date 09/2017
- GA51723 - Exp. Date 09/2017
- GA51760 - Exp. Date 10/2017
- and GA51761 - Exp. Date 10/2017 b) GA45033 - Exp. Date 10/2016
- GA50258 - Exp. Date 01/2017
- GA50944 - Exp. Date 05/2017
- GA50174 - Exp. Date 06/2017
- GA51340 - Exp. Date 07/2017
- GA51479 - Exp. Date 08/2017
- and GA51762 - Exp. Date 10/2017
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Par Pharmaceutical, Inc.
See all →- SeverePar Pharmaceutical Recalls BusPIRone Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2020-09-02
- SeverePar Pharmaceutical Recalls Glycopyrrolate Tablets Due to Unknown Impurity
FDA (Drugs) · 2020-04-08
- LowPar Pharmaceutical Recalls Prednisone Tablets Due to Incorrect Expiration Date
FDA (Drugs) · 2020-03-25
- LowPar Pharmaceutical Recalls Frovatriptan Tablets Due to Incorrect Expiration Date
FDA (Drugs) · 2020-02-19
- SeverePar Pharmaceutical Recalls Mycophenolate Mofetil Injection Due to Glass Fragment
FDA (Drugs) · 2019-05-15
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29