Quick answers
- What is Isopto Atropine?
- Isopto Atropine is a brand name of Atropine, a prescription medicine. The FDA NDC Directory lists 1 Isopto Atropine product in 1 strength and form.
- Who makes Isopto Atropine?
- Alcon Labs Inc holds the FDA application for Isopto Atropine (NDA208151, approved December 1, 2016).
- Is there a generic or store brand of Isopto Atropine?
- Yes. The FDA NDC Directory lists 3 other products with the same active ingredients, strength and form as a Isopto Atropine product, 1 of them generic. Ask your pharmacist whether one is right for you.
- Has Isopto Atropine been recalled?
- FDA enforcement reports list 1 recall of Isopto Atropine products; the newest started April 13, 2022. A recall usually concerns specific lots, not every product.
What Isopto Atropine is
Each Isopto Atropine product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Atropine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| atropine sulfate 10 mg/mL solution (ophthalmic) | Isopto Atropine | 3 products, 3 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Atropine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA208151 | Alcon Labs Inc | December 1, 2016 | 1 |
Companies that list Isopto Atropine
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Isopto Atropine products.
- Alcon Laboratories, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1035-2022
cGMP deviations: Temperature abuse
Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55 — Mckesson Medical-Surgical Inc. Corporate Office
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.