Class III · Low risk
Aminocaproic Acid Oral Solution
Failed Excipient Specifications: high content of ethylene glycol (EG)
Is Aminocaproic Acid recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Aminocaproic Acid (5 total). Check the affected lots below.
Most common reason: Sterility / contamination (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Aminocaproic Acid. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Aminocaproic Acid recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
Aminocaproic Acid
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Class II · Moderate risk
Aminocaproic Acid active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Aminocaproic Acid 0.5mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Aminocaproic Acid 250 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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