Fluorescein 2% Ophth recall
FDA recall D-0607-2025 · initiated Jul 9, 2025
Boothwyn Pharmacy LLC recalled Fluorescein 2% Ophth in Jul 2025 — an FDA Class III recall (D-0607-2025) because Subpotent Drug.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8 vials
Details
- Product
- Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
- Recalling company
- Boothwyn Pharmacy LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Jul 9, 2025
- FDA report date
- Sep 10, 2025
Frequently asked
- Was Fluorescein 2% Ophth recalled?
- Boothwyn Pharmacy LLC recalled Fluorescein 2% Ophth in Jul 2025 — an FDA Class III recall (D-0607-2025) because Subpotent Drug. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Fluorescein 2% Ophth recalled?
- Per the FDA enforcement record, the reason for recall D-0607-2025 was: Subpotent Drug
- Is a recalled Fluorescein 2% Ophth dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fluorescein 2% Ophth are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — 06092025@23 BUD 09/09/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0607-2025.