Why it was recalled
Lack of Assurance of Sterility
Product description
B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0044-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 30, 2025
- FDA report date
- Oct 15, 2025
- Quantity
- 35
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GenoGenix LLC
Original FDA data
Every field from FDA enforcement report D-0044-2026, exactly as published.
Show all FDA fields
- City
- Boca Raton
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 97369
- Address
- 2840 Nw 2nd Ave Ste 204
- Code information
- All lots within expiry.
- Postal code
- 33431-6692
- Report date
- Oct 15, 2025
- Product type
- Drugs
- Recall number
- D-0044-2026
- Classification
- Class II
- Recalling firm
- GenoGenix LLC
- Product quantity
- 35
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Jul 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 21, 2025