Duloxetine product
Reason category: Impurities (e.g. nitrosamines)
FDA recall number D-0617-2026
Mental health
Duloxetine DR 60 mg capsule
Public data on duloxetine 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.
$0.1368
NADAC per ea (2026-11)
approximate acquisition cost, not a retail price
-0%
change over five years
peak $5.9211 in 2014-02
23
approved generic applications (ANDAs) on record for Duloxetine Hydrochloride
16 with a product still marketed · first 2013
Not listed
in FDA's current shortage list
no matching FDA shortage entries
NADAC per unit, monthly
DULOXETINE HCL DR 60 MG CAPShow as table
| Month | NADAC per unit ($) |
|---|---|
| 2014-02 | 5.92112 |
| 2014-05 | 5.41108 |
| 2014-08 | 4.93238 |
| 2014-11 | 1.21831 |
| 2015-02 | 0.87335 |
| 2015-05 | 0.73808 |
| 2015-08 | 0.68529 |
| 2015-11 | 0.55012 |
| 2016-02 | 0.48569 |
| 2016-05 | 0.40666 |
| 2016-08 | 0.34796 |
| 2016-11 | 0.30487 |
| 2017-02 | 0.26904 |
| 2017-05 | 0.26382 |
| 2017-08 | 0.24394 |
| 2017-11 | 0.22710 |
| 2018-02 | 0.22235 |
| 2018-05 | 0.19096 |
| 2018-08 | 0.20887 |
| 2018-11 | 0.17830 |
| 2019-02 | 0.16645 |
| 2019-05 | 0.16737 |
| 2019-08 | 0.17409 |
| 2019-11 | 0.17072 |
| 2020-02 | 0.16336 |
| 2020-05 | 0.16479 |
| 2020-08 | 0.15569 |
| 2020-11 | 0.15759 |
| 2021-02 | 0.14940 |
| 2021-05 | 0.13792 |
| 2021-08 | 0.13754 |
| 2021-11 | 0.13709 |
| 2022-02 | 0.12505 |
| 2022-05 | 0.11736 |
| 2022-08 | 0.11186 |
| 2022-11 | 0.11722 |
| 2023-02 | 0.11195 |
| 2023-05 | 0.11411 |
| 2023-08 | 0.11157 |
| 2023-11 | 0.11275 |
| 2024-02 | 0.11589 |
| 2024-05 | 0.09829 |
| 2024-08 | 0.10073 |
| 2024-11 | 0.09341 |
| 2025-02 | 0.10076 |
| 2025-05 | 0.10864 |
| 2025-08 | 0.09615 |
| 2025-11 | 0.09341 |
| 2026-02 | 0.09973 |
| 2026-05 | 0.12676 |
| 2026-08 | 0.12924 |
| 2026-11 | 0.13680 |
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 duloxetine
openFDA enforcement records, by year reported.
| 2026 | 8 |
| 2025 | 28 |
| 2024 | 13 |
| 2018 | 1 |
| 2017 | 2 |
| 2016 | 5 |
| 2015 | 2 |
| 2014 | 4 |
63 records since 2012. A record is one product or lot, not one recall event. Combination products that contain duloxetine 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
Duloxetine hydrochloride delayed-release capsules
Reason category: Impurities (e.g. nitrosamines)
FDA recall number D-0583-2026
Duloxetine hydrochloride delayed-release capsules
Reason category: Impurities (e.g. nitrosamines)
FDA recall number D-0582-2026
Duloxetine capsules
Reason category: Impurities (e.g. nitrosamines)
FDA recall number D-0555-2026
Duloxetine delayed-release capsules
Reason category: Impurities (e.g. nitrosamines)
FDA recall number D-0514-2026
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 duloxetine
16 GxRadar articles cite or discuss this drug.
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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 · 6 min
What pharmacies paid for six generic antidepressants, 2013 to 2026
Federal NADAC data for sertraline, escitalopram, citalopram, fluoxetine, trazodone and duloxetine show three very different price paths since 2013, and FDA approval records help explain them.
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.
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.
Case histories · History · 6 min
How a carcinogen in blood pressure pills changed generic drug testing
Since 2018, nitrosamine impurities have produced nearly 500 federal recall records, pushed ranitidine off the US market and led FDA to set daily intake limits for impurities formed from the drug itself.
Generic or brand · Explainer · 6 min
Extended-release, delayed-release and immediate-release pills, and how FDA judges their generics
ER, XL, DR and the rest describe how a pill lets go of its drug. What the formulations are, how FDA tests generic copies of each, what the Orange Book codes say, and what our recall data show.