Class II · Moderate risk
Dapiprazole
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Is Dapiprazole recalled?
Not under an active recall.
Dapiprazole was recalled 3 times in the past — all now closed. Most recent: Sep 12, 2015.
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 Dapiprazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Dapiprazole recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Dapiprazole HCl 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
Dapiprazole Ophthalmic 0.5% Solution 10 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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