Class II · Moderate risk
Tacrolimus Ophthalmic
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Is Tacrolimus recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Tacrolimus (27 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tacrolimus. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tacrolimus recalls on record
none so far in 2026; 27 on record, newest first
Class II · Moderate risk
Mylan
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
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