Tadalafil usp
Reason category: cGMP deviations
FDA recall number D-0761-2026
Prostate / ED
Tadalafil 5 mg tablet
Public data on tadalafil from CMS and FDA: what pharmacies have paid for it, how many generic applications FDA has approved, and whether it appears in FDA's shortage or recall records.
$0.1078
NADAC per ea (2026-11)
approximate acquisition cost, not a retail price
-23%
change over five years
peak $8.2575 in 2018-12
44
approved generic applications (ANDAs) on record for Tadalafil
39 with a product still marketed · first 2018
Not listed
in FDA's current shortage list
no matching FDA shortage entries
NADAC per unit, monthly
TADALAFIL 5 MG TABLETShow as table
| Month | NADAC per unit ($) |
|---|---|
| 2018-12 | 8.25752 |
| 2019-03 | 8.09481 |
| 2019-06 | 4.29212 |
| 2019-09 | 0.37298 |
| 2019-12 | 0.26289 |
| 2020-03 | 0.29791 |
| 2020-06 | 0.26491 |
| 2020-09 | 0.26772 |
| 2020-12 | 0.27163 |
| 2021-03 | 0.18750 |
| 2021-06 | 0.19191 |
| 2021-09 | 0.17981 |
| 2021-12 | 0.13628 |
| 2022-03 | 0.18367 |
| 2022-06 | 0.13295 |
| 2022-09 | 0.13327 |
| 2022-12 | 0.14114 |
| 2023-03 | 0.13268 |
| 2023-06 | 0.14426 |
| 2023-09 | 0.15283 |
| 2023-12 | 0.17499 |
| 2024-03 | 0.14655 |
| 2024-06 | 0.13075 |
| 2024-09 | 0.16243 |
| 2024-12 | 0.09223 |
| 2025-03 | 0.11055 |
| 2025-06 | 0.11094 |
| 2025-09 | 0.12173 |
| 2025-12 | 0.11092 |
| 2026-03 | 0.10439 |
| 2026-06 | 0.10416 |
| 2026-09 | 0.10216 |
Source: CMS NADAC weekly files, generic rows, monthly median of weekly averages · data as of 2026-11. Figures can change and may contain errors in the source data. Check the original source before relying on them.
Recall records mentioning tadalafil
openFDA enforcement records, by year reported.
| 2026 | 3 |
| 2023 | 8 |
| 2021 | 2 |
| 2020 | 7 |
| 2018 | 3 |
| 2015 | 2 |
25 records since 2012. A record is one product or lot, not one recall event. Combination products that contain tadalafil are included.
What these numbers mean
NADAC is what retail pharmacies pay on average to buy the drug, published by CMS. It does not include rebates and is not what you pay at the counter. ANDA counts include all strengths and forms and applications whose products are now discontinued.
Most recent recall records
Tadalafil usp
Reason category: cGMP deviations
FDA recall number D-0760-2026
Tadalafil usp
Reason category: cGMP deviations
FDA recall number D-0762-2026
Tadalafil tablets
Reason category: cGMP deviations
FDA recall number D-0554-2023
Tadalafil tablets
Reason category: cGMP deviations
FDA recall number D-0553-2023
Not health advice. GxRadar is for general information only. Nothing here is medical, pharmacy, legal or financial advice. Do not start, stop or change any medicine based on this site. Talk to your pharmacist or prescriber about your own situation.
Articles that mention tadalafil
12 GxRadar articles cite or discuss this drug.
Price histories · Data story · 6 min
How fast generic prices fell for rosuvastatin, duloxetine and tadalafil
Federal cost data show three widely used generics each fell more than 90 percent within 24 months of entry. One did it in five weeks. Month-by-month figures, lined up against FDA approval dates.
Price histories · Data story · 5 min
How the price of generic sildenafil 20 mg fell 92 percent
Federal NADAC data show a generic 20 mg sildenafil tablet fell from 65.9 cents in 2013 to 5.2 cents in 2026, mostly after 2016. FDA approval records for both sets of strengths, and a tadalafil comparison.
FDA programs · Data story · 5 min
What FDA's yearly first generics lists show
FDA's 2025 first generics list has 91 entries, but one entry is not one medicine and approval is not launch. What the lists count, and what price data show after a first copy arrives.
Market economics · Explainer · 5 min
Why generic prices fall as competitors enter
One generic maker cuts the brand price by about 39 percent; six or more cut it by over 95 percent. FDA's 2019 study, GAO data and GxRadar's NADAC files show how steep the curve is and why.
Market economics · Explainer · 5 min
What happens to Medicaid spending when the first generic arrives
Federal research on prices after generic entry, and four worked examples from NADAC and Medicaid claims data: duloxetine, valsartan, rosuvastatin and tadalafil.
Recall data · Data story · 6 min
What FDA's Class I drug recall records show
FDA put 1,753 drug recall records in its most serious class between mid-2012 and October 2026. GxRadar sorted them by year, event and reason to see what actually ends up there.