Quick answers
- What is Prednisolone acetate used for?
- The FDA-approved label (Pred Mild, Allergan, Inc., November 25, 2025) says: “PRED MILD ® is indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Prednisolone acetate have a boxed warning?
- No. None of the 15 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Prednisolone acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Prednisolone acetate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started June 4, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Prednisolone acetate?
- 10 companies list prescription products of Prednisolone acetate in the FDA NDC Directory, including A-S Medication Solutions, Amneal Pharmaceuticals NY LLC and Allergan, Inc..
What Prednisolone acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PRED MILD ® is indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns).
— FDA label: Pred Mild, Allergan, Inc., effective November 25, 2025. Read the full label on DailyMed →
The FDA has 15 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 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Suspension/ drops |
|---|---|
| Route | Ophthalmic |
| Prescription products | 17 in the FDA NDC Directory |
| Brand names | Pred Forte, Pred Mild |
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 |
|---|---|---|
| prednisolone acetate 1.2 mg/mL suspension/ drops | Brand: Pred Mild | $30.64–$30.64 per mL 2 packages, lowest to highest |
| prednisolone acetate 10 mg/mL suspension/ drops | Generic | $4.71–$5.06 per mL 12 packages, lowest to highest |
| prednisolone acetate 10 mg/mL suspension/ drops | Brand: Pred Forte | $30.71 per mL |
NADAC list of November 4, 2026; these prices took effect between December 17, 2025 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.
- A-S Medication Solutions4 products
- Amneal Pharmaceuticals NY LLC3 products
- Allergan, Inc.2 products
- Sportpharm LLC2 products
- NuCare Pharmaceuticals, Inc.1 product
- Redpharm Drug1 product
- Pacific Pharma, Inc.1 product
- Sandoz Inc1 product
- Asclemed USA, Inc.1 product
- Lupin 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 |
|---|---|---|---|
| NDA017011 PRED FORTE | Abbvie | May 30, 1973 | 30, latest June 6, 2018 2018: Labeling · 2017: Labeling · 2002: Manufacturing (CMC) |
| NDA017100 PRED MILD | Abbvie | November 10, 1972 | 36, latest November 25, 2025 2025: Manufacturing (CMC) · 2022: Labeling · 2022: Labeling |
| NDA017469 OMNIPRED | Sandoz | July 10, 1973 | 34, latest December 18, 2024 2024: Labeling · 2022: Labeling · 2007: Labeling |
Generic approvals (2)
- ANDA216935Lupin · August 2, 2024
- ANDA218256Amneal · June 11, 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.
-
June 4, 2026 · Class II · Ongoing · D-0655-2026
Presence of Foreign Substance
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA — Lupin Pharmaceuticals Inc.
-
May 18, 2026 · Class III · Ongoing · D-0551-2026
Failed Stability Specifications
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10. — AbbVie Inc.
-
April 13, 2022 · Class II · Terminated · D-1105-2022
cGMP deviations: Temperature abuse
Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05 — Mckesson Medical-Surgical Inc. Corporate Office
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) | 209002, 562379, 1376336, 1548724 |
|---|---|
| SPL set ID of the quoted label | 4fcce64a-94ea-4031-ad5a-c4eddc73a910 |
| FDA labels (SPL) | 15 |
| FDA applications | NDA017011, NDA017100, NDA017469, 2 ANDA |
| Active ingredients (FDA) | PREDNISOLONE ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pred Mild, Allergan, Inc., effective November 25, 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 →