HIGHFDA DRUG

Boothwyn Pharmacy Fluorescein 2% Ophth 3 mL Recall for Subpotent Drug (High Risk)

Boothwyn Pharmacy recalls 8 vials of Fluorescein 2% Ophth 3 mL nationwide after a subpotent drug finding. The recall was issued July 9, 2025 and remains active.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
July 9, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
July 9, 2025
Hazard Level
HIGH
Brand
Boothwyn Pharmacy
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Boothwyn Pharmacy
Product type
Ophthalmic Solution
Model numbers
06092025@23 BUD 09/09/2025
Sizes
3 mL
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    July 9, 2025

  2. Reported by FDA DRUG

    September 10, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Subpotent Drug

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Boothwyn Pharmacy LLC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

About This Product

Ophthalmic fluorescein solutions are used during eye exams and procedures to highlight corneal irregularities.

Why This Is Dangerous

Subpotent drug may fail to provide adequate therapeutic effect during diagnostic or treatment procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers and healthcare providers should stop using the product immediately and seek guidance from Boothwyn Pharmacy or a healthcare provider.

Practical Guidance

How to identify if yours is affected

  1. Verify the lot/model number: 06092025@23 BUD 09/09/2025
  2. Check packaging for identical labeling and expiry date 09/09/2025 if present
  3. Confirm nationwide distribution status with recall notice

Where to find product info

FDA enforcement reports and Boothwyn Pharmacy recall communications

What timeline to expect

Refund or replacement timelines are provided by Boothwyn Pharmacy and may take weeks

If the manufacturer is unresponsive

  • Document all contact attempts
  • Escalate to FDA MedWatch if Boothwyn Pharmacy is unresponsive
  • Consider contacting your healthcare provider for alternatives and guidance

How to prevent similar issues

  • Verify supplier's recalls before use
  • Maintain documentation of lot numbers
  • Consult pharmacist before using ophthalmic meds in case of shortages or recalls

Documentation advice

Keep recall notice, packaging, and correspondence with Boothwyn Pharmacy for your records

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Product Details

Brand: Boothwyn Pharmacy. Product: Fluorescein 2% Ophth, 3 mL. Quantity: 8 vials. Distribution: U.S. nationwide. Recall date: 2025-07-09. Model: 06092025@23 BUD 09/09/2025.

Reported Incidents

No injuries or incidents information provided in the notice.

Key Facts

  • 8 total units recalled
  • Recall active as of 2025-09-10
  • Class III recall
  • High hazard level

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
ELECTRICALPOISONINGLACERATIONBURNSUFFOCATIONOTHER

Product Details

Model Numbers
06092025@23 BUD 09/09/2025
Affected States
ALL
Report Date
September 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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