Bromfenac recalls

The FDA has published 7 recalls involving Bromfenac since 2015. The latest was reported on 4 Jun 2025. Most were for sterility. Apotex has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls7since 2015

Last 12 months0reported

Class I00% of total

Ongoing1latest 4 Jun 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 1 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 6 86%Class III 1 14%

Why bromfenac is recalled

Companies

Brands

Bromfenac Ophthalmic Solution 0.09%229%
Bromsite114%

By year

2025114%
2021114%
2019114%
2016114%
2015343%

Ongoing bromfenac recalls

1 active

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09%	Alembic Pharmaceuticals	Potency & Assay	Nationwide

All bromfenac recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09%	Alembic Pharmaceuticals	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Cardinal HealthBromfenac Ophthalmic Solution 0.09%	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
6 Feb 2019Drug	CLASS II	BromSite (bromfenac ophthalmic solution) recalledBromsite	Sun Pharmaceutical Industries	Sterility	Nationwide
27 Jan 2016Drug	CLASS II	Bromfenac Ophthalmic Solution 0.09%, a) bottles recalled	Mayne Pharma Usa	Sterility	Nationwide
21 Oct 2015Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Apotex	Apotex	Sterility	Nationwide
26 Aug 2015Drug	CLASS II	Bromfenac Ophthalmic Solution recalled by Bausch & Lomb	Bausch & Lomb	Sterility	Nationwide
22 Apr 2015Drug	CLASS III	Bromfenac Ophthalmic Solution recalled by Apotex	Apotex	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Bromfenac?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.