Quick answers
- What is Pregabalin used for?
- The FDA-approved label (Lyrica, Viatris Specialty LLC, April 15, 2025) says: “LYRICA is indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pregabalin have a boxed warning?
- No. None of the 225 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pregabalin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pregabalin been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started May 16, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Pregabalin?
- 51 companies list prescription products of Pregabalin in the FDA NDC Directory, including Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC and Proficient Rx LP.
What Pregabalin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LYRICA is indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for …
— FDA label: Lyrica, Viatris Specialty LLC, effective April 15, 2025. Read the full label on DailyMed →
The FDA has 225 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.
The label quoted above has no boxed warning.
0 of 225 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 |
|---|---|---|
| pregabalin 100 mg capsule | Generic | $0.0602 per capsule |
| pregabalin 100 mg capsule | Brand: Lyrica | $9.69 per capsule |
| pregabalin 150 mg capsule | Generic | $0.0585 per capsule |
| pregabalin 150 mg capsule | Brand: Lyrica | $9.68 per capsule |
| pregabalin 165 mg tablet, film coated, extended release | Generic | $1.63 per tablet |
| pregabalin 20 mg/mL solution | Generic | $0.1485 per mL |
| pregabalin 200 mg capsule | Generic | $0.0623 per capsule |
| pregabalin 200 mg capsule | Brand: Lyrica | $9.68 per capsule |
| pregabalin 225 mg capsule | Generic | $0.0683 per capsule |
| pregabalin 225 mg capsule | Brand: Lyrica | $9.68 per capsule |
| pregabalin 25 mg capsule | Generic | $0.0446 per capsule |
| pregabalin 25 mg capsule | Brand: Lyrica | $9.68 per capsule |
| pregabalin 300 mg capsule | Generic | $0.0690 per capsule |
| pregabalin 300 mg capsule | Brand: Lyrica | $9.67 per capsule |
| pregabalin 330 mg tablet, film coated, extended release | Generic | $2.23 per tablet |
| pregabalin 50 mg capsule | Generic | $0.0477 per capsule |
| pregabalin 50 mg capsule | Brand: Lyrica | $9.68 per capsule |
| pregabalin 75 mg capsule | Generic | $0.0556 per capsule |
| pregabalin 75 mg capsule | Brand: Lyrica | $9.67 per capsule |
| pregabalin 82.5 mg tablet, film coated, extended release | Generic | $2.35 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 Prepack42 products
- Aphena Pharma Solutions - Tennessee, LLC42 products
- Proficient Rx LP39 products
- Remedyrepack Inc.24 products
- ScieGen Pharmaceuticals, Inc.19 products
- Asclemed USA, Inc.16 products
- Advanced Rx Pharmacy of Tennessee, LLC16 products
- Amneal Pharmaceuticals NY LLC16 products
- Cipla USA Inc.16 products
- Westminster Pharmaceuticals, LLC16 products
- Clinical Solutions Wholesale, LLC14 products
- Viatris Specialty LLC12 products
- Novadoz Pharmaceuticals LLC11 products
- Preferred Pharmaceuticals Inc.11 products
- St. Mary's Medical Park Pharmacy11 products
- Direct_Rx10 products
- Ascend Laboratories, LLC9 products
- Eskayef Pharmaceuticals Limited8 products
- Exelan Pharmaceuticals Inc.8 products
- Fourrts (India) Laboratories Private Limited8 products
- Indoco Remedies Limited8 products
- Marksans Pharma Limited8 products
- Unichem Pharmaceuticals (USA), Inc.8 products
- Camber Pharmaceuticals, Inc.8 products
- Macleods Pharmaceuticals Limited8 products
- Dr.Reddys Laboratories Inc8 products
- Alembic Pharmaceuticals Inc.8 products
- Rising Pharma Holdings, Inc.8 products
- Creekwood Pharmaceuticals LLC8 products
- Solco Healthcare US, LLC8 products
- Aurobindo Pharma Limited8 products
- Advanced Rx of Tennessee, LLC8 products
- Major Pharmaceuticals8 products
- Alembic Pharmaceuticals Limited8 products
- Sun Pharmaceutical Industries, Inc.8 products
- Cadila Pharmaceuticals Limited8 products
- Golden State Medical Supply, Inc.8 products
- Torrent Pharmaceuticals Limited8 products
- NorthStar RxLLC7 products
- Tris Pharma Inc7 products
- A-S Medication Solutions6 products
- American Health Packaging5 products
- AvPAK5 products
- Quality Care Products, LLC5 products
- Chartwell RX, LLC4 products
- Coupler LLC3 products
- Advagen Pharma Ltd3 products
- Cardinal Health 107, LLC3 products
- Parke-Davis Div of Pfizer Inc1 product
- Patrin Pharma, Inc.1 product
- Mylan Pharmaceuticals Inc.1 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 |
|---|---|---|---|
| NDA021446 LYRICA | Upjohn | December 30, 2004 | 22, latest April 25, 2025 2025: Labeling · 2023: Labeling · 2020: Labeling |
| NDA022488 LYRICA | Upjohn | January 4, 2010 | 15, latest April 25, 2025 2025: Labeling · 2023: Labeling · 2020: Labeling |
| NDA209501 LYRICA CR | Upjohn | October 11, 2017 | 3, latest April 25, 2025 2025: Labeling · 2023: Labeling · 2020: Labeling |
Generic approvals (29)
- ANDA203459Alembic · July 19, 2019
- ANDA207623Alkem Labs Ltd · July 19, 2019
- ANDA207799Alkem Labs Ltd · July 19, 2019
- ANDA208677Sciegen Pharms · July 19, 2019
- ANDA209357Msn · July 19, 2019
- ANDA209664DR Reddys · July 19, 2019
- ANDA209743Amneal Pharms Co · July 19, 2019
- ANDA210432Rising · July 19, 2019
- ANDA211384Invagen Pharms · July 19, 2019
- ANDA206912Hetero Labs Ltd III · October 8, 2019
- ANDA091157Sun Pharm · November 29, 2019
- ANDA212280Cipla · January 10, 2020
- ANDA212865Chartwell Rx · March 20, 2020
- ANDA213423Creekwood Pharms · March 23, 2020
- ANDA213226Msn · April 13, 2021
- ANDA214322Tris Pharma Inc · July 15, 2021
- ANDA212604Anda Repository · February 18, 2022
- ANDA212988Pharmazone · March 8, 2022
- ANDA215249Rubicon Research · March 22, 2022
- ANDA216197Pharmazone · July 18, 2022
- ANDA207883Prinston Inc · September 1, 2022
- ANDA215675Sciegen Pharms · September 14, 2022
- ANDA205321Aurobindo Pharma · March 29, 2023
- ANDA206452Cadila Pharms Ltd · July 12, 2023
- ANDA208113Regcon Holdings · May 17, 2024
- ANDA205924Macleods Pharms · November 12, 2024
- ANDA206942Torrent · February 21, 2025
- ANDA218529Caplin · February 24, 2026
- ANDA219593Unichem · April 30, 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.
-
May 16, 2024 · Class III · Ongoing · D-0541-2024
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10 — Rising Pharma Holding, Inc.
-
October 22, 2021 · Class II · Terminated · D-0361-2022
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. — SUN PHARMACEUTICAL INDUSTRIES INC
-
March 15, 2021 · Class II · Terminated · D-0469-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES — Cardinal Health Inc.
-
January 11, 2016 · Class II · Terminated · D-0648-2016
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68 — Pfizer Inc.
-
January 11, 2016 · Class II · Terminated · D-0649-2016
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68 — Pfizer 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) — Lyrica, Viatris Specialty LLC, effective April 15, 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 →