FDA Recall D-0607-2025
Boothwyn Pharmacy LLC · Kennett Square, PA
Class III Ongoing 309 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Reason for recall
Subpotent Drug
Recall record
- Recall number
D-0607-2025- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- U.S. Nationwide
- Recall initiated
- 2025-07-09
- Classified by FDA Center
- 2025-08-29
- FDA published
- 2025-09-10
- Recalling firm
- Boothwyn Pharmacy LLC
- Firm location
- Kennett Square, PA
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.