Class II · ModerateRecall completed
Tadalafil
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b) P2002521, Exp. Date 4/30/2023; P2005818, Exp. Date 10/31/2023; P2100075, Exp. Date 12/31/2023; P2100996, P2100997, P2100998, P2100999, Exp. Date 1/31/2024;
Where it was soldUnited States including Puerto Rico and Canada
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: recalling drug products following an FDA inspection.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA foreign manufacturer
| Brand name | TADALAFIL |
| Generic name | TADALAFIL |
| Active ingredient(s) | TADALAFIL |
| Distributed by / for | Accord Healthcare, Inc., Durham, NC 27703 |
| NDC | 16729-369-10 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Accord Healthcare, Inc. |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 36,773 bottles |
| Recall initiated | 2023-02-07 |
| Report date | 2023-03-08 |
| Recall completed | 2024-04-22 |
| Recall number | D-0414-2023 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Durham NC United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.