Why it was recalled
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Product description
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Lot numbers, UPCs & expiration codes
Lot #: 40187.2, Exp. Date 2/2026
Where it was sold
Nationwide within the USA
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-0611-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 17, 2025
- FDA report date
- Sep 10, 2025
- Quantity
- 249 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- DermaRite Industries, LLC
Original FDA data
Every field from FDA enforcement report D-0611-2025, exactly as published.
Show all FDA fields
- City
- North Bergen
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97277
- Address
- 7777 W Side Ave
- Code information
- Lot #: 40187.2, Exp. Date 2/2026
- Postal code
- 07047-6436
- Report date
- Sep 10, 2025
- Product type
- Drugs
- Recall number
- D-0611-2025
- Classification
- Class I
- Recalling firm
- DermaRite Industries, LLC
- Product quantity
- 249 bottles
- Reason for recall
- Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- Jul 17, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 2, 2025