Class III · Low risk
Diflorasone Diacetate Ointment
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Is Diflorasone recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Diflorasone (4 total). Check the affected lots below.
Most common reason: Stability / shelf life (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Diflorasone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Diflorasone recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
Diflorasone Diacetate Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Diflorasone Diacetate Ointment USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Diflorasone Diacetate Ointment USP
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
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