TADALAFIL

Generic: TADALAFIL

Dr.Reddys Laboratories IncManufacturer
ORALRoute
TADALAFILActive Substance
2019-03-26Original Approval

TADALAFIL is FDA application ANDA210069, sponsored by DR REDDYS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2023-03-23
Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC

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

Class II2023-02-07
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-co

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-03-16
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-

CGMP Deviations

Class II2023-02-07
Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-c

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-c

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-coun

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-03-16
Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203

CGMP Deviations

Class II2021-10-25
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufacture

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the produc

Class II2021-10-25
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactur

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the produc

Top Reported Reactions

1
DYSPNOEA
4,110 reports
2
HEADACHE
3,657 reports
3
DIARRHOEA
3,029 reports
4
NAUSEA
2,476 reports
5
FATIGUE
2,405 reports
6
COUGH
1,927 reports
7
DIZZINESS
1,866 reports
8
DEATH
1,472 reports
9
OFF LABEL USE
1,320 reports
10
VOMITING
1,288 reports