Compounded fluorescein ophthalmic solution recalled after testing subpotent in one lot
Fluorescein 2% Ophthalmic, 3 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 8 vials are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The rubric puts FDA Class III actions at 1 or 2, and this is a potency shortfall in a diagnostic ophthalmic solution with no health consequence described.
Plain-English summary
Fluorescein 2% Ophthalmic, 3 mL, from Boothwyn Pharmacy is being recalled. The affected product carries code 06092025@23 with a beyond-use date of 09/09/2025. The recall covers 8 vials distributed nationwide.
The recall was issued because the product is subpotent. The FDA classified the action as Class III.
Holders of this lot should follow the pharmacy's instructions for return or replacement.
The recalled product
- Product
- Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
- Manufacturer
- Boothwyn Pharmacy LLC
- Category
- Drug — Ophthalmic
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 06092025@23 BUD 09/09/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Boothwyn Pharmacy LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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