Tropicamide recalls

The FDA has published 11 recalls involving Tropicamide since 2012. The latest was reported on 17 Dec 2025. Most were for sterility. Fagron Compounding Services 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 recalls11since 2012

Last 12 months1reported

Class I00% of total

Ongoing4latest 17 Dec 2025

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 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 8 73%Class III 3 27%

Why tropicamide is recalled

Companies

By year

202519%
2023327%
202219%
2016218%
2015218%
201419%
201219%

Ongoing tropicamide recalls

4 active

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS II	Tropicamide 1%/Cyclopentolate 1%/Phenylephrine recalled	Fagron Compounding Services	Packaging Defects	Nationwide
6 Dec 2023Drug	CLASS III	Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL) recalled	Fagron Compounding Services	Packaging Defects	Nationwide
7 Jun 2023Drug	CLASS II	Tropicamide Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Tropicamide Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide

All tropicamide recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS II	Tropicamide 1%/Cyclopentolate 1%/Phenylephrine recalled	Fagron Compounding Services	Packaging Defects	Nationwide
6 Dec 2023Drug	CLASS III	Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL) recalled	Fagron Compounding Services	Packaging Defects	Nationwide
7 Jun 2023Drug	CLASS II	Tropicamide Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Tropicamide Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
15 Jun 2022Drug	CLASS II	Tropicamide Ophthalmic Solution recalled by Mckesson Medical-Surgical	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
3 Feb 2016Drug	CLASS III	Tropicamide Ophthalmic Solution recalled by Bausch & LombTropicamide	Bausch & Lomb	Packaging Defects	Nationwide
3 Feb 2016Drug	CLASS III	Tropicamide Ophthalmic Solution recalled by Bausch & LombTropicamide	Bausch & Lomb	Packaging Defects	Nationwide
25 Nov 2015Drug	CLASS II	Tropicamide 1%/Phenylephrine recalled by US Compounding	US Compounding	Sterility	Nationwide
25 Nov 2015Drug	CLASS II	Tropicamide 0.5%/ Phenylephrine 5% Dropper Bottle recalled	US Compounding	Sterility	Nationwide
22 Jan 2014Drug	CLASS II	Tropicamide* 1% Ophthalmic Solution recalled by Specialty Medicine	Specialty Medicine Compounding Pharmacy	Sterility	MI
22 Aug 2012Drug	CLASS II	Tropicamide/phenylephrine Ophthalmic 15:1 Solution recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Tropicamide?

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.