Class II · Moderate risk
All hydroxyurea Products
Lack of Processing Controls
Is Hydroxyurea recalled?
Not under an active recall.
Hydroxyurea was recalled 3 times in the past — all now closed. Most recent: Mar 25, 2016.
Most common reason: cGMP deviation (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydroxyurea. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hydroxyurea recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Hydroxyurea 100 mg/1 mL Susp
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Hydroxyurea 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.
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