Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10…

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

Recalling firm

Accord Healthcare, Inc.

NDC code

16729-370-10

Origin

NC, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0415-2023

Other Tadalafil recalls

See all

Class II · Moderate risk Ongoing Aug 3, 2026

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no…

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-001-08 D-0762-2026

Class II · Moderate risk Ongoing Aug 3, 2026

TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey…

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-002-04 D-0761-2026

Class II · Moderate risk Ongoing Aug 3, 2026

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey…

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-002-02 D-0760-2026

Class II · Moderate risk Ongoing Mar 23, 2023

Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC…

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 Mar 20, 2023

Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00

Reason cGMP Deviations

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