US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2020 (6 years ago)

Tadalafil 12 mg Capsule

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Processing Controls (lack of assurance of conformity to specifications).

What was recalled

Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

Recalling firm
MasterPharm LLC
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1436-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Tadalafil recalls

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Class II · Moderate risk Ongoing

Tadalafil USP

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-001-08 D-0762-2026
Class II · Moderate risk Ongoing

Tadalafil USP

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-002-04 D-0761-2026
Class II · Moderate risk Ongoing

Tadalafil USP

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-002-02 D-0760-2026
Class II · Moderate risk Ongoing

Tadalafil Tablets

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8153-7 D-0526-2023
Class II · Moderate risk Terminated

Tadalafil 5 mg tablets

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-2972-00 D-0497-2023