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Drug FDA Class III Ongoing Sub/super-potent

Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496

Boothwyn Pharmacy LLC Published Sep 10, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Boothwyn Pharmacy LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Subpotent Drug

Hazards

Subpotency · primary

Affected products (1)

Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496

8 vials

Code info: 06092025@23 BUD 09/09/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 9, 2025
  2. Published
    Sep 10, 2025
Recall number
D-0607-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.