Pilocarpine recalls

The FDA has published 5 recalls involving Pilocarpine since 2017. The latest was reported on 7 Jun 2023. 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 2017

Last 12 months0reported

Class I00% of total

Ongoing3latest 7 Jun 2023

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 4 80%Class III 1 20%

Why pilocarpine is recalled

Potency & Assay480%
Manufacturing (CGMP) Deviations120%

Companies

Akorn360%
Mckesson Medical-Surgical Inc. Corporate Office120%
Novartis Pharmaceuticals120%

By year

2023360%
2022120%
2017120%

Ongoing pilocarpine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Pilocarpine Hydrochloride Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Pilocarpine Hydrochloride Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Pilocarpine Hydrochloride Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide

All pilocarpine recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Pilocarpine Hydrochloride Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Pilocarpine Hydrochloride Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Pilocarpine Hydrochloride Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
15 Jun 2022Drug	CLASS II	Pilocarpine HCL Ophthalmic Solution recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
3 May 2017Drug	CLASS III	Pilocarpine Hydrochloride Ophthalmic Solution recalledPilocarpine Hydrochloride	Novartis Pharmaceuticals	Potency & Assay	Nationwide

Should you stop taking Pilocarpine?

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.