Tadalafil recalls: 9 FDA reports
Recalls involving Tadalafil. What was wrong with each batch, and how the FDA graded the risk.
9Reports
0Class I
3Ongoing
2023-05-03Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC
D-0553-2023 · Class II · reported 2023-05-03 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
- Where it went
- Nationwide with the United States
- How much
- a)164 bottles; b) 198 bottles
Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis
D-0554-2023 · Class II · reported 2023-05-03 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52
- Where it went
- Nationwide with the United States
- How much
- 23 bottles
Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC
D-0526-2023 · Class II · reported 2023-04-12 · Ongoing
- Why it was recalled
- cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
- Product
- Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7
- Where it went
- USA Nationwide
- How much
- 32 Bottles
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0;
D-0416-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Where it went
- United States including Puerto Rico and Canada
- How much
- 176,323 bottles
Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7
D-0414-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- 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-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Where it went
- United States including Puerto Rico and Canada
- How much
- 36,773 bottles
Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7
D-0417-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Where it went
- United States including Puerto Rico and Canada
- How much
- 613,553 bottles
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b
D-0415-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Where it went
- United States including Puerto Rico and Canada
- How much
- 1,113,264 bottles
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, M
D-0230-2022 · Class II · reported 2021-11-17 · Terminated
- Why it was recalled
- Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
- Product
- Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
- Where it went
- Distributed to one distributor who may have further distribute the product nationwide.
- How much
- 73,957 30-count bottles
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141,
D-0231-2022 · Class II · reported 2021-11-17 · Terminated
- Why it was recalled
- Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
- Product
- Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01
- Where it went
- Distributed to one distributor who may have further distribute the product nationwide.
- How much
- 36,786 30-count bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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