Aminocaproic Acid recalls

The FDA has published 5 recalls involving Aminocaproic Acid since 2013. The latest was reported on 26 Aug 2026. Most were for sterility. Lowlite Investments 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 2013

Last 12 months1reported

Class I00% of total

Ongoing3latest 26 Aug 2026

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 1Aug 0 0

Severity split

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

Why aminocaproic acid is recalled

Companies

By year

2026120%
2023120%
2017120%
2013240%

Ongoing aminocaproic acid recalls

3 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid	American Regent	Particulate Matter	Nationwide
17 Jul 2013Drug	CLASS II	Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Aminocaproic Acid 250 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

All aminocaproic acid recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid	American Regent	Particulate Matter	Nationwide
6 Dec 2023Drug	CLASS III	Aminocaproic Acid Oral Solution/mL recalled by VistaPharm	VistaPharm	Packaging Defects	Nationwide
27 Sep 2017Drug	CLASS II	Aminocaproic Acid, USP (6-Aminohexanoic Acid) active recalled by Medisca	Medisca	Manufacturing (CGMP) Deviations	Nationwide
17 Jul 2013Drug	CLASS II	Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia recalled	Lowlite Investments	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Aminocaproic Acid 250 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

Should you stop taking Aminocaproic Acid?

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.