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.
What this means for you
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
- Hazard
- subpotency
- compounded-drug
- class-iii
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.
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