Class II · Moderate risk
Minoxidil 0.75%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Is Minoxidil recalled?
Not under an active recall.
Minoxidil was recalled 12 times in the past — all now closed. Most recent: Dec 22, 2022.
Most common reason: cGMP deviation (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Minoxidil. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Minoxidil recalls on record
none so far in 2026; 12 on record, newest first
Class II · Moderate risk
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Minoxidil/Biotin 1.25mg/5mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I · High risk
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule
Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Class II · Moderate risk
MINOXADIL all strength including 2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Minoxidil 0.5% W/Pres.
Lack of Assurance of Sterility
Class II · Moderate risk
Minoxidil active pharmaceutical ingredient packaged in varying…
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
Minoxidil
Labeling: Label Mixup:MINOXIDIL, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD52778_43, EXP: 5/20/2014.
Class II · Moderate risk
Minoxidil 15% 60ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Minoxidil 10% 60ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
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