CLASS III ONGOING Drug recall · Reported 10 Sep 2025 · FDA Enforcement Report
Fluorescein 2% Ophth, Boothwyn Pharmacy recalled
Boothwyn Pharmacy is recalling Fluorescein 2% Ophth, Boothwyn Pharmacy, 800-476-7496, distributed nationwide in the US. The recall was initiated on 9 Jul 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0607-2025
- FDA event ID
- 97202
- Recalling firm
- Boothwyn Pharmacy, Kennett Square, PA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 9 Jul 2025
- FDA classified
- 29 Aug 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
Timeline
| 9 Jul 2025 | Recall initiated by company | |
| 29 Aug 2025 | Classified by FDA | +51 days |
| 10 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
06092025@23 BUD 09/09/2025
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 97202This product is part of a recall event; the main page for the event is Semaglutide, 2.5 mg/mL injection, Boothwyn Pharmacy recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Semaglutide, 2.5 mg/mL injection, Boothwyn Pharmacy recalled | Boothwyn Pharmacy | Potency & Assay | Nationwide | |
| CLASS II | Semaglutide, 2.5 mg/mL injection, Boothwyn Pharmacy recalled | Boothwyn Pharmacy | Potency & Assay | Nationwide | |
| CLASS II | Semaglutide, 2.5 mg/mL injection, Boothwyn Pharmacy recalled | Boothwyn Pharmacy | Potency & Assay | Nationwide |
More recalls from Boothwyn Pharmacy
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Semaglutide, 2.5 mg/mL injection, Boothwyn Pharmacy recalled | Boothwyn Pharmacy | Potency & Assay | Nationwide |
| Drug | CLASS II | Semaglutide, 2.5 mg/mL injection, Boothwyn Pharmacy recalled | Boothwyn Pharmacy | Potency & Assay | Nationwide |
| Drug | CLASS II | Semaglutide, 2.5 mg/mL injection, Boothwyn Pharmacy recalled | Boothwyn Pharmacy | Potency & Assay | Nationwide |