Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Is Tacrolimus recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Tacrolimus (27 total). Check the affected lots below.
Most common reason: Sterility / contamination (10 of these recalls)
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 I · High risk
Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class II · Moderate risk
Tacrolimus 0.03% Oph Solution Tacrolimus 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class III · Low risk
Tacrolimus Ointment
Defective Container: Tube split from side seam
Class I · High risk
Tacrolimus
Subpotent drug
Class I · High risk
Tacrolimus
Subpotent drug
Class III · Low risk
NDC 64380-721-06 Tacrolimus Capsules
Failed Moisture Limits
Class III · Low risk
Tacrolimus Capsules
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Class II · Moderate risk
C-Tacrolimus 0.03% Ophthal Suspension
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
Tacrolimus USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
All tacrolimus Products
Lack of Processing Controls
Class II · Moderate risk
Tacrolimus 0.03% Opth Oint
Lack of Assurance of Sterility
Class II · Moderate risk
Tacrolimus 0.02% Opth Sol
Lack of Assurance of Sterility
Class II · Moderate risk
Tacrolimus Monohydrate active pharmaceutical ingredient packaged…
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
Tacrolimus oil 0.03% opthalmic solution packaged in an opaque squeeze bottle eye dropper
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Tacrolimus 0.02% opth.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Tacrolimus
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Tacrolimus Capsules
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Class II · Moderate risk
TACROLIMUS Capsule
Labeling: Label Mixup; TACROLIMUS, Capsule, 1 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 125 mcg, NDC 00074706890, Pedigree: AD70633_4, EXP: 5/23/2014.
Class II · Moderate risk
Tacrolimus
Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 5 mg, NDC 29300012601, Pedigree: AD34934_7, EXP: 5/10/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD56917_4, EXP: 5/21/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD73627_11, EXP: 5/30/2014; ATOMOXE
Class II · Moderate risk
Tacrolimus
Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003168, EXP: 6/13/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: W003350, EXP: 6/18/2014.
Class II · Moderate risk
Tacrolimus
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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