Class III · Low risk
Milrinone Lactate Injection
Failed Impurities/Degradation Specifications
Is Milrinone recalled?
Not under an active recall.
Milrinone was recalled 9 times in the past — all now closed. Most recent: Aug 14, 2023.
Most common reason: Sterility / contamination (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Milrinone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Milrinone recalls on record
none so far in 2026; 9 on record, newest first
Class II · Moderate risk
Milrinone
Lack of sterility assurance
Class II · Moderate risk
Milrinone Lactate Injection 200 mcg
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
Milrinone Lactate Injection 200 mcg
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
Milrinone Lactate in 5% Dextrose Injection
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk
Milrinone 200 mcg/mL in a) D5W-300 mL
Lack of Sterility Assurance
Class II · Moderate risk
Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Milrinone in 0.45% NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Milrinone various strengths in dextrose
Lack of sterility assurance.
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