Prednisolone and bromfenac ophthalmic recalls

The FDA has published 1 recall involving Prednisolone and bromfenac ophthalmic since 2019. The latest was reported on 20 Feb 2019. Most were for sterility. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2019

Last 12 months0reported

Class I00% of total

Ongoing0latest 20 Feb 2019

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why prednisolone and bromfenac ophthalmic is recalled

Sterility1100%

Companies

Promise Pharmacy1100%

By year

20191100%

All prednisolone and bromfenac ophthalmic recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
20 Feb 2019Drug	CLASS II	Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops recalled	Promise Pharmacy	Sterility	Nationwide

Should you stop taking Prednisolone and bromfenac ophthalmic?

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.