Quick answers
- What is Buspirone used for?
- The FDA-approved label (Bucapsol, Pangea Pharmaceuticals, LLC, July 13, 2026) says: “Bucapsol TM capsules are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Buspirone have a boxed warning?
- No. None of the 167 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Buspirone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Buspirone been recalled?
- FDA enforcement reports list 10 recalls of products of this medicine; the newest started April 13, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Buspirone?
- 45 companies list prescription products of Buspirone in the FDA NDC Directory, including Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC and A-S Medication Solutions.
What Buspirone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Bucapsol TM capsules are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. …
— FDA label: Bucapsol, Pangea Pharmaceuticals, LLC, effective July 13, 2026. Read the full label on DailyMed →
The FDA has 167 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.
The label quoted above has no boxed warning.
0 of 167 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 276 in the FDA NDC Directory |
| Brand names | Bucapsol |
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 |
|---|---|---|
| buspirone hydrochloride 10 mg tablet | Generic | $0.0277 per tablet |
| buspirone hydrochloride 15 mg tablet | Generic | $0.0431 per tablet |
| buspirone hydrochloride 30 mg tablet | Generic | $0.1229 per tablet |
| buspirone hydrochloride 5 mg tablet | Generic | $0.0218 per tablet |
| buspirone hydrochloride 7.5 mg tablet | Generic | $0.0998 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- Bryant Ranch Prepack38 products
- Aphena Pharma Solutions - Tennessee, LLC20 products
- A-S Medication Solutions19 products
- Proficient Rx LP12 products
- Epic Pharma, LLC12 products
- Remedyrepack Inc.12 products
- Direct_Rx8 products
- PD-Rx Pharmaceuticals, Inc.7 products
- Cardinal Health 107, LLC7 products
- Unichem Pharmaceuticals (USA), Inc.6 products
- NuCare Pharmaceuticals, Inc.6 products
- Asclemed USA, Inc.6 products
- Advagen Pharma Ltd5 products
- Radha Pharmaceuticals, Inc.5 products
- AiPing Pharmaceutical, Inc.5 products
- Golden State Medical Supply, Inc.5 products
- Aurobindo Pharma Limited5 products
- Strides Pharma Science Limited5 products
- Rising Pharma Holdings, Inc.5 products
- Zydus Lifesciences Limited5 products
- Zydus Pharmaceuticals USA Inc.5 products
- NCS HealthCare of KY, LLC dba Vangard Labs5 products
- Strides Pharma Inc.5 products
- Northwind Health Company, LLC5 products
- Accord Healthcare Inc.5 products
- Apnar Pharma LP5 products
- Safecor Health LLC4 products
- Preferred Pharmaceuticals Inc.4 products
- Mylan Pharmaceuticals Inc.4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 products
- Oxford Pharmaceuticals, LLC4 products
- Mylan Institutional Inc.4 products
- Pangea Pharmaceuticals, LLC4 products
- Major Pharmaceuticals3 products
- American Health Packaging3 products
- Unit Dose Solutions, Inc.3 products
- Advanced Rx Pharmacy of Tennessee, LLC3 products
- IPG Pharmaceuticals, Inc.2 products
- Coupler LLC2 products
- Boswell Pharmacy Services LLC d/b/a BPS Wholesale1 product
- Advanced Rx of Tennessee, LLC1 product
- Boswell Pharmacy Services d/b/a BPS Wholesale1 product
- Redpharm Drug1 product
- AvPAK1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (16)
- ANDA076008Mylan · June 28, 2001
- ANDA075022Teva · February 28, 2002
- ANDA075413Rising · March 19, 2002
- ANDA075521Rubicon Research · April 5, 2002
- ANDA075388Oxford Pharms · May 9, 2002
- ANDA078302Oxford Pharms · December 17, 2007
- ANDA078246Aurobindo Pharma Ltd · February 27, 2009
- ANDA078888Zydus Pharms · February 7, 2014
- ANDA202330Strides Pharma · August 25, 2014
- ANDA202557Accord Hlthcare · December 30, 2014
- ANDA204582Heritage Pharma · September 18, 2015
- ANDA202087Aiping Pharm Inc · December 16, 2015
- ANDA209696Adaptis · May 3, 2018
- ANDA208972Epic Pharma LLC · April 16, 2019
- ANDA210907Unichem · November 14, 2019
- ANDA218628Epic Pharma LLC · March 13, 2025
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.
-
April 13, 2026 · Class III · Ongoing · D-0511-2026
Subpotent drug
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. Ea — Unichem Pharmaceuticals USA Inc.
-
October 27, 2023 · Class III · Terminated · D-0113-2024
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141. — NCS Healthcare of Kentucky Inc
-
October 27, 2023 · Class III · Terminated · D-0114-2024
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141. — NCS Healthcare of Kentucky Inc
-
March 16, 2023 · Class II · Ongoing · D-0549-2023
CGMP Deviations
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52 — Northwind Pharmaceuticals LLC
-
February 7, 2023 · Class II · Terminated · D-0375-2023
CGMP Deviations: recalling drug products following an FDA inspection.
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16 — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0378-2023
CGMP Deviations: recalling drug products following an FDA inspection.
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 167 — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0377-2023
CGMP Deviations: recalling drug products following an FDA inspection.
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 167 — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0376-2023
CGMP Deviations: recalling drug products following an FDA inspection.
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; Manufactured for: Accord Healthcare, Inc., Durham — Accord Healthcare, Inc.
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February 7, 2023 · Class II · Terminated · D-0379-2023
CGMP Deviations: recalling drug products following an FDA inspection.
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 1672 — Accord Healthcare, Inc.
-
May 5, 2021 · Class II · Completed · D-0602-2021
Presence of Foreign Tablets/Capsules
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10 — Oxford Pharmaceuticals, LLC
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) — Bucapsol, Pangea Pharmaceuticals, LLC, effective July 13, 2026; 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 →