Proline recalls

The FDA has published 2 recalls involving Proline since 2016. The latest was reported on 15 Oct 2025. Most were for sterility. GenoGenix 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 recalls2since 2016

Last 12 months1reported

Class I00% of total

Ongoing1latest 15 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 1 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why proline is recalled

Sterility2100%

Companies

GenoGenix150%
Medaus150%

By year

2025150%
2016150%

Ongoing proline recalls

1 active

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Proline for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide

All proline recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Proline for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Proline 100MG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide

Should you stop taking Proline?

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.