Quick answers
- What is Clobetasol propionate used for?
- The FDA-approved label (Byqlovi, Harrow Eye, LLC, January 26, 2026) says: “BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery. BYQLOVI is a corticosteroid indicated for the treatment of post- operative inflammation and pain following ocular surgery.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clobetasol propionate have a boxed warning?
- The label we quote has no boxed warning, but 1 of 104 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Clobetasol propionate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clobetasol propionate been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started August 3, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clobetasol propionate?
- 41 companies list prescription products of Clobetasol propionate in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Sun Pharmaceutical Industries, Inc..
What Clobetasol propionate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery. BYQLOVI is a corticosteroid indicated for the treatment of post- operative inflammation and pain following ocular surgery.
— FDA label: Byqlovi, Harrow Eye, LLC, effective January 26, 2026. Read the full label on DailyMed →
The FDA has 104 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.
1 of 104 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream · Ointment · Solution · Shampoo · Aerosol, foam · Gel · Spray · Lotion · For suspension · Suspension/ drops |
|---|---|
| Route | Topical · Ophthalmic |
| Prescription products | 113 in the FDA NDC Directory |
| Brand names | Clobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation), Clobetasol Propionate Emollient Formulation, Clodan, Clobetasol Propionate Anda, Impoyz |
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 |
|---|---|---|
| clobetasol propionate 0.05 g/mL spray | Generic | $0.2223–$0.3443 per mL 6 packages, lowest to highest |
| clobetasol propionate 0.05% aerosol, foam | Generic | $0.3259–$2.23 per gram 13 packages, lowest to highest |
| clobetasol propionate 0.05% cream | Generic | $0.1301–$0.6721 per gram 38 packages, lowest to highest |
| clobetasol propionate 0.05% gel | Generic | $0.4081–$1.06 per gram 6 packages, lowest to highest |
| clobetasol propionate 0.05% lotion | Generic | $0.2825–$0.3463 per mL 6 packages, lowest to highest |
| clobetasol propionate 0.05% ointment | Generic | $0.1130–$0.1562 per gram 36 packages, lowest to highest |
| clobetasol propionate 0.05% shampoo | Generic | $0.2227 per mL |
| clobetasol propionate 0.4625 mg/mL solution | Generic | $0.1583 per mL |
| clobetasol propionate 0.5 mg/mL lotion | Generic | $0.2825–$0.3463 per mL 2 packages, lowest to highest |
| clobetasol propionate 0.5 mg/mL shampoo | Generic | $0.2227 per mL |
| clobetasol propionate 0.5 mg/mL solution | Generic | $0.1583–$0.2453 per mL 11 packages, lowest to highest |
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 Prepack24 products
- A-S Medication Solutions11 products
- Sun Pharmaceutical Industries, Inc.9 products
- Alembic Pharmaceuticals Inc.6 products
- Alembic Pharmaceuticals Limited6 products
- Padagis Israel Pharmaceuticals Ltd4 products
- Lupin Pharmaceuticals, Inc.4 products
- Encube Ethicals, Inc.3 products
- Zydus Lifesciences Limited3 products
- Macleods Pharmaceuticals Limited3 products
- NorthStar Rx LLC3 products
- Xiromed, LLC2 products
- Proficient Rx LP2 products
- AvKARE2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Novel Laboratories, Inc.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Harrow Eye, LLC1 product
- Amneal Pharmaceuticals NY LLC1 product
- Direct_Rx1 product
- Cosette Pharmaceuticals, Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Aurobindo Pharma Limited1 product
- NuCare Pharmaceuticals, Inc.1 product
- Actavis Pharma, Inc.1 product
- Micro Labs Limited1 product
- Quagen Pharmaceuticals LLC1 product
- Eyenovia, Inc.1 product
- Medimetriks Pharmaceuticals, Inc.1 product
- Remedyrepack Inc.1 product
- NorthStar RxLLC1 product
- Medimetriks Pharmaceuticals1 product
- Mayne Pharma Inc.1 product
- Viona Pharmaceuticals Inc1 product
- INA Pharmaceutics Inc1 product
- Torrent Pharmaceuticals Limited1 product
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC1 product
- Primus Pharmaceuticals, Inc.1 product
- The J. Molner Company LLC1 product
- Amneal 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 |
|---|---|---|---|
| NDA021644 CLOBEX | Galderma Labs | February 5, 2004 | 2, latest November 30, 2012 2012: Labeling · 2012: Labeling |
| NDA209483 IMPOYZ | Primus Pharms | November 28, 2017 | — |
| NDA218158 BYQLOVI | Harrow Eye | March 4, 2024 | 1, latest April 7, 2025 2025: Labeling |
Generic approvals (48)
- ANDA074089Cosette Pharms Nc · February 16, 1994
- ANDA074249Sun Pharma Canada · July 8, 1996
- ANDA074248Sun Pharma Canada · July 12, 1996
- ANDA074392Fougera Pharms Inc · September 30, 1996
- ANDA075027Padagis Us · October 31, 1997
- ANDA075057Aurobindo Pharma USA · August 12, 1998
- ANDA075224Sun Pharma Canada · November 16, 1998
- ANDA075391Fougera Pharms · February 8, 1999
- ANDA075279Sun Pharma Canada · May 28, 1999
- ANDA075633Sun Pharma Canada · May 17, 2000
- ANDA076977Encube · August 5, 2005
- ANDA077763Padagis Israel · March 10, 2008
- ANDA078223Actavis Mid Atlantic · December 4, 2008
- ANDA200302Sun Pharma Canada · July 2, 2012
- ANDA090974Padagis Israel · August 9, 2012
- ANDA201402Padagis Israel · August 14, 2012
- ANDA206075Novel Labs Inc · November 23, 2015
- ANDA206378Zydus Pharms · February 16, 2017
- ANDA208933Glenmark Speclt · March 20, 2017
- ANDA209411Beach Prods · August 21, 2017
- ANDA209147Lupin · September 22, 2017
- ANDA209361Macleods Pharms · October 25, 2017
- ANDA210199Zydus Pharms · October 27, 2017
- ANDA210208Lupin · January 30, 2018
- ANDA208842Sun Pharma Canada · March 26, 2018
- ANDA209701Xiromed · April 17, 2018
- ANDA208841Novel Labs Inc · May 4, 2018
- ANDA210034Xiromed · June 15, 2018
- ANDA208779Taro · October 4, 2018
- ANDA211256Amneal · December 26, 2018
- ANDA210809Glenmark Pharms Ltd · February 15, 2019
- ANDA211800Alembic · March 4, 2019
- ANDA211450Glenmark Pharms Ltd · September 9, 2019
- ANDA205249Zydus Lifesciences · September 24, 2019
- ANDA211191Alembic · October 2, 2019
- ANDA211494Saptalis Pharms · October 2, 2019
- ANDA212881Alembic · October 21, 2019
- ANDA211295Encube · November 15, 2019
- ANDA211836Torrent · December 30, 2019
- ANDA213291Alembic · January 27, 2020
Showing the 40 earliest of 48.
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.
-
August 3, 2026 · Class II · Ongoing · D-0789-2026
Failed content uniformity specifications.
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04. — Lupin Pharmaceuticals Inc.
-
January 20, 2023 · Class III · Terminated · D-0174-2023
Subpotent Drug: Low assay result observed during long-term stability testing.
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03 — Lupin Pharmaceuticals Inc.
-
December 15, 2021 · Class I · Terminated · D-0375-2022
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3 — Taro Pharmaceuticals U.S.A., Inc.
-
November 15, 2019 · Class III · Terminated · D-0619-2020
Defective delivery system; product is not foaming or is coming out as liquid.
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Auran — Glenmark Pharmaceuticals Inc., USA
-
November 15, 2019 · Class III · Terminated · D-0618-2020
Defective delivery system; product is not foaming or is coming out as liquid.
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharash — Glenmark Pharmaceuticals Inc., USA
-
January 11, 2019 · Class III · Terminated · D-0492-2019
Defective Container; complaints of leakage.
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA — Oxalis Labs
-
December 21, 2017 · Class III · Terminated · D-0249-2018
Failed Content Uniformity Specifications
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 516 — Taro Pharmaceuticals U.S.A., Inc.
-
June 2, 2017 · Class III · Terminated · D-0945-2017
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W La — G & W Laboratories, 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) — Byqlovi, Harrow Eye, LLC, effective January 26, 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 →