Difluprednate recalls

The FDA has published 4 recalls involving Difluprednate since 2022. The latest was reported on 14 Sep 2022. 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 recalls4since 2022

Last 12 months0reported

Class I00% of total

Ongoing0latest 14 Sep 2022

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why difluprednate is recalled

Sterility4100%

Companies

Cipla4100%

By year

20224100%

All difluprednate recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
14 Sep 2022Drug	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate	Cipla	Sterility	Nationwide
14 Sep 2022Drug	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLA	Cipla	Sterility	Nationwide
17 Aug 2022Drug	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate	Cipla	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate	Cipla	Sterility	Nationwide

Should you stop taking Difluprednate?

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.