Quick answers
- What is Paroxetine used for?
- The FDA-approved label (Brisdelle, Legacy Pharma USA, Inc., April 28, 2025) says: “BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Limitations of Use: BRISDELLE is not indicated for the treatment of any psychiatric condition. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Paroxetine have a boxed warning?
- Yes. The FDA label for Brisdelle has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Paroxetine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Paroxetine been recalled?
- FDA enforcement reports list 16 recalls of products of this medicine; the newest started September 23, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Paroxetine?
- 43 companies list prescription products of Paroxetine in the FDA NDC Directory, including Remedyrepack Inc., Apotex Corp. and Aphena Pharma Solutions - Tennessee, LLC.
What Paroxetine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Limitations of Use: BRISDELLE is not indicated for the treatment of any psychiatric condition. …
— FDA label: Brisdelle, Legacy Pharma USA, Inc., effective April 28, 2025. Read the full label on DailyMed →
The FDA has 83 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
. Read it on the full label →
81 of 83 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| paroxetine hydrochloride 10 mg tablet, film coated | Generic | $0.0634 per tablet |
| paroxetine hydrochloride 12.5 mg tablet, film coated, extended release | Generic | $0.4823 per tablet |
| paroxetine hydrochloride 20 mg tablet, film coated | Generic | $0.0625 per tablet |
| paroxetine hydrochloride 20 mg tablet, film coated | Brand: Paxil | $10.74 per tablet |
| paroxetine hydrochloride 25 mg tablet, film coated, extended release | Generic | $0.3980 per tablet |
| paroxetine hydrochloride 25 mg tablet, film coated, extended release | Brand: Paxil CR | $10.80 per tablet |
| paroxetine hydrochloride 30 mg tablet, film coated | Generic | $0.0991 per tablet |
| paroxetine hydrochloride 30 mg tablet, film coated | Brand: Paxil | $10.81 per tablet |
| paroxetine hydrochloride 37.5 mg tablet, film coated, extended release | Generic | $0.4394 per tablet |
| paroxetine hydrochloride 40 mg tablet, film coated | Generic | $0.0979 per tablet |
| paroxetine hydrochloride 40 mg tablet, film coated | Brand: Paxil | $11.50 per tablet |
| paroxetine hydrochloride anhydrous 10 mg tablet, film coated | Generic | $0.0634 per tablet |
| paroxetine hydrochloride anhydrous 20 mg tablet, film coated | Generic | $0.0625 per tablet |
| paroxetine hydrochloride anhydrous 30 mg tablet, film coated | Generic | $0.0991 per tablet |
| paroxetine hydrochloride anhydrous 40 mg tablet, film coated | Generic | $0.0979 per tablet |
| paroxetine hydrochloride hemihydrate 10 mg tablet, film coated | Generic | $0.0634 per tablet |
| paroxetine hydrochloride hemihydrate 10 mg/5 mL suspension | Generic | $1.40 per mL |
| paroxetine hydrochloride hemihydrate 12.5 mg tablet, film coated, extended release | Generic | $0.4823 per tablet |
| paroxetine hydrochloride hemihydrate 20 mg tablet, film coated | Generic | $0.0625 per tablet |
| paroxetine hydrochloride hemihydrate 25 mg tablet, film coated, extended release | Generic | $0.3980 per tablet |
| paroxetine hydrochloride hemihydrate 30 mg tablet, film coated | Generic | $0.0991 per tablet |
| paroxetine hydrochloride hemihydrate 37.5 mg tablet, film coated, extended release | Generic | $0.4394 per tablet |
| paroxetine hydrochloride hemihydrate 40 mg tablet, film coated | Generic | $0.0979 per tablet |
| paroxetine mesylate 7.5 mg capsule | Generic | $2.64 per capsule |
NADAC list of November 4, 2026; these prices took effect between August 19, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Remedyrepack Inc.14 products
- Apotex Corp.14 products
- Aphena Pharma Solutions - Tennessee, LLC9 products
- Chartwell RX, LLC7 products
- Proficient Rx LP7 products
- Bryant Ranch Prepack7 products
- Preferred Pharmaceuticals Inc.7 products
- PD-Rx Pharmaceuticals, Inc.5 products
- Solco Healthcare US, LLC4 products
- Aurobindo Pharma Limited4 products
- NuCare Pharmaceuticals, Inc.4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Yiling Pharmaceutical, Inc.4 products
- NorthStar Rx LLC4 products
- Aurolife Pharma, LLC4 products
- Asclemed USA, Inc.4 products
- NCS HealthCare of KY, LLC dba Vangard Labs4 products
- American Health Packaging4 products
- Oxford Pharmaceuticals, LLC4 products
- Mylan Pharmaceuticals Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Zydus Lifesciences Limited4 products
- Modavar Pharmaceuticals LLC3 products
- AvPAK3 products
- Alembic Pharmaceuticals Limited3 products
- Lupin Pharmaceuticals, Inc.3 products
- Alembic Pharmaceuticals Inc.3 products
- Cadila Pharmaceuticals Limited3 products
- A-S Medication Solutions3 products
- Westminster Pharmaceuticals, LLC3 products
- Lannett Company, LLC3 products
- Coupler LLC2 products
- Direct_Rx2 products
- Major Pharmaceuticals2 products
- NuCare Pharamceuticals, Inc.1 product
- ANI Pharmaceuticals, Inc.1 product
- Hawaii Repack, Inc.1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- Cardinal Health 107, LLC1 product
- Legacy Pharma USA Inc.1 product
- Padagis US LLC1 product
- Solco Healthcare LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020031 PAXIL | Apotex | December 29, 1992 | 64, latest September 23, 2026 2026: Labeling · 2024: Labeling · 2023: Labeling |
| NDA020936 PAXIL CR | Apotex | February 16, 1999 | 42, latest September 23, 2026 2026: Labeling · 2024: Labeling · 2023: Labeling |
| NDA204516 BRISDELLE | Legacy | June 28, 2013 | 9, latest February 11, 2025 2025: Labeling · 2025: Labeling · 2023: Labeling |
Generic approvals (15)
- ANDA075356Apotex · July 30, 2003
- ANDA077584Zydus Pharms USA · March 7, 2007
- ANDA078406Aurobindo Pharma · July 25, 2007
- ANDA078902Mylan · March 13, 2008
- ANDA076968Oxford Pharms · June 21, 2010
- ANDA203854Prinston Inc · October 31, 2014
- ANDA204744Lannett Co Inc · June 10, 2016
- ANDA204134Lupin · January 20, 2017
- ANDA207188Prinston Inc · August 18, 2017
- ANDA213485Cspc Ouyi · February 16, 2021
- ANDA212645Cadila Pharms Ltd · August 27, 2021
- ANDA215003Novitium Pharma · September 3, 2021
- ANDA211248Pharmobedient · November 2, 2021
- ANDA217280Alembic · September 24, 2025
- ANDA219954Annora Pharma · March 5, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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September 23, 2026 · Class II · Ongoing · D-0877-2026
Failed dissolution specifications.
Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3 — Apotex Corp.
-
August 13, 2026 · Class II · Ongoing · D-0804-2026
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3 — Apotex Corp.
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November 10, 2023 · Class II · Terminated · D-0129-2024
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorpor — Golden State Medical Supply Inc.
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November 10, 2023 · Class II · Terminated · D-0130-2024
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canad — Golden State Medical Supply Inc.
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November 10, 2023 · Class II · Terminated · D-0128-2024
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canad — Golden State Medical Supply Inc.
-
November 1, 2023 · Class II · Ongoing · D-0119-2024
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontar — Apotex Corp.
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November 1, 2023 · Class II · Ongoing · D-0120-2024
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apo — Apotex Corp.
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November 1, 2023 · Class II · Ongoing · D-0122-2024
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326. — Apotex Corp.
-
November 1, 2023 · Class II · Ongoing · D-0121-2024
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, — Apotex Corp.
-
November 20, 2017 · Class II · Terminated · D-0101-2018
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distri — Zydus Pharmaceuticals USA Inc
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October 24, 2017 · Class II · Terminated · D-0091-2018
Presence of Foreign Tablets/Capsules.
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01 — Amerisource Health Services
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August 18, 2017 · Class II · Terminated · D-1137-2017
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 — Zydus Pharmaceuticals USA Inc
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June 22, 2017 · Class III · Terminated · D-0974-2017
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: — Lupin Pharmaceuticals Inc.
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March 24, 2014 · Class II · Terminated · D-1577-2014
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3 — Apotex Inc.
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March 24, 2014 · Class II · Terminated · D-1576-2014
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3 — Apotex Inc.
-
March 24, 2014 · Class II · Terminated · D-1574-2014
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3 — Apotex Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Brisdelle, Legacy Pharma USA, Inc., effective April 28, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →