Proparacaine recalls

The FDA has published 5 recalls involving Proparacaine since 2020. The latest was reported on 2 Oct 2024. Most were for potency & assay. Akorn 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 recalls5since 2020

Last 12 months0reported

Class I00% of total

Ongoing3latest 2 Oct 2024

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 4 80%Class III 1 20%

Why proparacaine is recalled

Companies

By year

2024120%
2023360%
2020120%

Ongoing proparacaine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Proparacaine HCl Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% per dropper recalled	Akorn	Manufacturing (CGMP) Deviations	Nationwide
25 Jan 2023Drug	CLASS II	Proparacaine Hydrochloride Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide

All proparacaine recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
2 Oct 2024Drug	CLASS II	Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile) recalledProparacaine Hydrochloride	Mckesson Medical-Surgical Inc. Corporate Office	Temperature Abuse	MD, VA
7 Jun 2023Drug	CLASS II	Proparacaine HCl Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% per dropper recalled	Akorn	Manufacturing (CGMP) Deviations	Nationwide
25 Jan 2023Drug	CLASS II	Proparacaine Hydrochloride Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
22 Jul 2020Drug	CLASS III	Proparacaine Hydrochloride Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide

Should you stop taking Proparacaine?

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.