CLASS III Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report

Bimatoprost Ophthalmic Solution recalled by Sandoz

Sandoz is recalling Bimatoprost Ophthalmic Solution 03%, distributed nationwide in the US. The recall was initiated on 17 Oct 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #s: a) 290635FA, 290635FB, Exp. 11/30/2019; 293230F, Exp. 6/30/2020; 294628F, 301337F, Exp. 11/30/2020; 304451FA, Exp. 1/31/2021. b) 290636FA, 290636FB, 290636FC, Exp. 11/30/2019; 293233FA, 293233FB, Exp. 5/31/2020; 293234FA, 293234FB, Exp. 6/30/2020; 294630F, 301338FA, 301338FB, 309426F, Exp. 11/30/2020; 304455FA, 304455FB Exp. 2/28/2021; 304883F, Exp. 4/30/2021; 312790F, Exp. 5/31/2021.

NDC0781-6206

Quantity recalled346,929 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-0161-2020
FDA event ID: 84082
Recalling firm: Sandoz, Princeton, NJ
Brand: Bimatoprost
Manufacturer: Sandoz Inc
Classification: Class III
Status: Terminated
Recall initiated: 17 Oct 2019
FDA classified: 28 Oct 2019
Reported: 6 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Eye Drops

Timeline

17 Oct 2019	Recall initiated by company
28 Oct 2019	Classified by FDA	+11 days
6 Nov 2019	Published in enforcement report	+9 days

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

Reason for recall

Labeling: Incorrect or missing package insert.

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

Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.

Where it was distributed

Nationwide in the U.S.

Nationwide

Questions about this recall

Is Bimatoprost Ophthalmic Solution 03% recalled?

Yes. Sandoz recalled Bimatoprost Ophthalmic Solution 03% on 17 Oct 2019. The recall is Class III and its status is Terminated. Recall number D-0161-2020.

Why was it recalled?

Labeling: Incorrect or missing package insert.

Which lots are affected?

Lot #s: a) 290635FA, 290635FB, Exp. 11/30/2019; 293230F, Exp. 6/30/2020; 294628F, 301337F, Exp. 11/30/2020; 304451FA, Exp. 1/31/2021. b) 290636FA, 290636FB, 290636FC, Exp. 11/30/2019; 293233FA, 293233FB, Exp. 5/31/2020; 293234FA, 293234FB, Exp. 6/30/2020; 294630F, 301338FA, 301338FB, 309426F, Exp. 11/30/2020; 304455FA, 304455FB Exp. 2/28/2021; 304883F, Exp. 4/30/2021; 312790F, Exp. 5/31/2021.

Where was it sold?

Nationwide in the U.S.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Bimatoprost recalls

All 4

Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Drug	CLASS II	Bimatoprost powder, Bulk Ingredient, a) recalled by Medisca	Medisca	Manufacturing (CGMP) Deviations	Nationwide
22 Nov 2017Drug	CLASS III	Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan	Allergan Sales	Potency & Assay	Nationwide
19 Apr 2017Drug	CLASS III	Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan	Allergan Sales	Potency & Assay	Nationwide