Class II · Moderate risk
Tadalafil USP
CGMP Deviations:Noted during FDA inspection
Is Tadalafil recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Tadalafil (25 total). Check the affected lots below.
Most common reason: cGMP deviation (18 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tadalafil. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tadalafil recalls in 2026
3 initiated in 2026, 25 in total — newest first
Class II · Moderate risk
Tadalafil USP
CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk
Tadalafil USP
CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk
Tadalafil Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Tadalafil 5 mg tablets
cGMP Deviations
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk
Tadalafil Tablets
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk
Tadalafil 7 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 3 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 26 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 18 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 12 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 6 mg Capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Tadalafil 20 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class III · Low risk
Tadalafil SR 12 mg Capsules packed in 8
Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk
Tadalafil SR 7 mg Capsules packed in 8
Labeling Not Elsewhere Classified: Misbranding.
Class II · Moderate risk
Tadalafil 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
Tadalafil Citrate 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
Tadalafil 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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