CLASS II Drug recall · Reported 7 Dec 2016 · FDA Enforcement Report

Travoprost Ophthalmic Solution USP, 0.004%, a) and b) recalled

Par Pharmaceutical is recalling Travoprost Ophthalmic Solution USP, 0.004%, a) and b), distributed nationwide in the US. The recall was initiated on 5 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 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

Quantity recalleda) 182,856 bottles; b) 59,448 bottles

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-0154-2017
FDA event ID: 75471
Recalling firm: Par Pharmaceutical, Chestnut Ridge, NY
Classification: Class II
Status: Terminated
Recall initiated: 5 Oct 2016
FDA classified: 25 Nov 2016
Reported: 7 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Eye Drops

Timeline

5 Oct 2016	Recall initiated by company
25 Nov 2016	Classified by FDA	+51 days
7 Dec 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container

Which lots are affected?

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

Where was it sold?

Nationwide

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 Par Pharmaceutical

All 17

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Other Travoprost recalls

All 4

Reported	Class	Recall	Company	Reason	Where
14 Jun 2023Drug	CLASS II	Travoprost Ophthalmic Solution recalled by Golden State Medical SupplyTravoprost	Golden State Medical Supply	Sterility	Nationwide
13 Apr 2022Drug	CLASS II	Travoprost Ophthalmic Solution recalled by Mylan PharmaceuticalsTravoprost Ophthalmic Solution, 0.004%	Mylan Pharmaceuticals	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Travoprost Ophthalmic Solution recalled by Cardinal Health	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC