Quick answers
- What is Baclofen used for?
- The FDA-approved label (Gablofen, Piramal Critical Care Inc, May 7, 2026) says: “GABLOFEN is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Baclofen have a boxed warning?
- Yes. The FDA label for Gablofen has a boxed warning (“WARNING: DO NOT DISCONTINUE ABRUPTLY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Baclofen?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Baclofen been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started November 26, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Baclofen?
- 61 companies list prescription products of Baclofen in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and A-S Medication Solutions.
What Baclofen is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
GABLOFEN is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. …
— FDA label: Gablofen, Piramal Critical Care Inc, effective May 7, 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.
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: DO NOT DISCONTINUE ABRUPTLY
. Read it on the full label →
10 of 167 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 |
|---|---|---|
| baclofen 10 mg tablet | Generic | $0.0326 per tablet |
| baclofen 10 mg/5 mL solution | Generic | $1.98 per mL |
| baclofen 15 mg tablet | Generic | $1.61 per tablet |
| baclofen 20 mg tablet | Generic | $0.0545 per tablet |
| baclofen 5 mg tablet | Generic | $0.0684 per tablet |
| baclofen 5 mg/5 mL solution | Generic | $1.04 per mL |
| baclofen 5 mg/mL suspension | Generic | $3.61–$3.79 per mL 4 packages, lowest to highest |
| baclofen 5 mg/mL suspension | Brand: Fleqsuvy | $5.98 per mL |
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 Prepack42 products
- Remedyrepack Inc.11 products
- A-S Medication Solutions8 products
- PD-Rx Pharmaceuticals, Inc.8 products
- Advagen Pharma Limited7 products
- Proficient Rx LP7 products
- Aphena Pharma Solutions - Tennessee, LLC7 products
- Advanced Rx of Tennessee, LLC7 products
- Preferred Pharmaceuticals Inc.7 products
- Advanced Rx Pharmacy of Tennessee, LLC6 products
- Method Pharmaceuticals, LLC6 products
- Asclemed USA, Inc.6 products
- Major Pharmaceuticals5 products
- TruPharma, LLC5 products
- Cardinal Health 107, LLC4 products
- NuCare Pharmaceuticals, Inc.4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Piramal Critical Care Inc4 products
- Sagent Pharmaceuticals4 products
- Amneal Pharmaceuticals LLC4 products
- Zydus Lifesciences Limited4 products
- Eywa Pharma Inc3 products
- Lannett Company, Inc.3 products
- XLCare Pharmaceuticals, Inc.3 products
- American Health Packaging3 products
- Chartwell RX, LLC3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Golden State Medical Supply, Inc.3 products
- AvPAK3 products
- Lifestar Pharma LLC3 products
- Aurobindo Pharma Limited3 products
- Rising Pharma Holdings, Inc.3 products
- Unichem Pharmaceuticals (USA), Inc.3 products
- Direct_Rx2 products
- MAlA Pharmaceuticals, Inc.2 products
- Teva Pharmaceuticals USA, Inc.2 products
- Redpharm Drug2 products
- Advagen Pharma Ltd2 products
- Par Health USA, LLC2 products
- NorthStar RxLLC2 products
- Marlex Pharmaceuticals, Inc.2 products
- MAIA Pharmaceuticals, Inc.2 products
- Medcore LLC2 products
- Wilshire Pharmaceuticals, Inc.1 product
- Northwind Health Company, LLC1 product
- Nexus Pharmaceuticals LLC1 product
- Anvi Pharmaceuticals Inc1 product
- Upsher-Smith Laboratories, LLC1 product
- Hawaii Repack, Inc.1 product
- Atlantic Biologicals Corp.1 product
- ANI Pharmaceuticals, Inc.1 product
- Palmetto Pharmaceuticals Inc.1 product
- Slayback Pharma LLC1 product
- Quality Care Products, LLC1 product
- Phoenix RX LLC1 product
- Coupler LLC1 product
- Rosemont Pharmaceuticals LLC1 product
- Acella Pharmaceuticals, LLC1 product
- Azurity Pharmaceuticals, Inc.1 product
- Trifluent Pharma, LLC1 product
- SOLA Pharmaceuticals, 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 |
|---|---|---|---|
| NDA020075 LIORESAL | Amneal | June 17, 1992 | 28, latest December 13, 2021 2021: Manufacturing (CMC) · 2019: Labeling · 2016: Manufacturing (CMC) |
| NDA022462 GABLOFEN | Piramal Critical | November 19, 2010 | 6, latest May 31, 2022 2022: Labeling · 2021: Labeling · 2019: Labeling |
| NDA208193 OZOBAX, OZOBAX DS | Rosemont | September 18, 2019 | 1, latest October 12, 2023 2023: Manufacturing (CMC) |
| NDA215422 LYVISPAH | Strides Pharma Intl | November 22, 2021 | — |
| NDA215602 FLEQSUVY | Azurity | February 4, 2022 | 1, latest April 18, 2024 2024: Manufacturing (CMC) |
Generic approvals (23)
- ANDA072234Ivax Sub Teva Pharms · July 21, 1988
- ANDA072235Ivax Sub Teva Pharms · July 21, 1988
- ANDA074584Pharmobedient · August 19, 1996
- ANDA077068Ph Health · August 30, 2005
- ANDA077241Lannett Co Inc · December 20, 2005
- ANDA078401Northstar Hlthcare · September 18, 2009
- ANDA078504Northstar Hlthcare · September 18, 2009
- ANDA209102Rubicon Research · November 28, 2017
- ANDA211659Zydus Lifesciences · November 23, 2018
- ANDA211555Adaptis · February 1, 2019
- ANDA210315Maia Pharms Inc · July 30, 2019
- ANDA210048Maia Pharms Inc · September 11, 2019
- ANDA212067Unichem · July 9, 2020
- ANDA212378Andas 5 Holding · October 9, 2020
- ANDA214374Rising · March 5, 2021
- ANDA214099Aurobindo Pharma Ltd · July 13, 2021
- ANDA215885Mankind Pharma · January 25, 2022
- ANDA217324Rubicon Research · February 22, 2023
- ANDA217252Ani Pharms · June 8, 2023
- ANDA214445Rubicon Research · December 6, 2024
- ANDA077156—
- ANDA078220—
- ANDA210777—
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.
-
November 26, 2025 · Class II · Ongoing · D-0235-2026
Presence of Foreign Tablets/Capsules
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10 — Golden State Medical Supply Inc.
-
July 8, 2019 · Class II · Terminated · D-1742-2019
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-0 — Piramal Critical Care, 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
| RxCUI (RxNorm) | 197391, 197392, 250976, 308516, 308517, 430902, 805678, 805679, 1047437, 1047440 … (+10) |
|---|---|
| SPL set ID of the quoted label | 00d3e846-dd92-448d-9ab8-6a07be823cc1 |
| FDA labels (SPL) | 167 |
| FDA applications | NDA020075, NDA022462, NDA208193, NDA215422, NDA215602, 23 ANDA |
| Active ingredients (FDA) | BACLOFEN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gablofen, Piramal Critical Care Inc, effective May 7, 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 →