DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite I… recall
FDA recall D-0165-2026 · initiated Aug 27, 2025
DermaRite Industries, LLC recalled DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, D… in Aug 2025 — an FDA Class II recall (D-0165-2026) because CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,389 bottles
Details
- Product
- DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
- Recalling company
- DermaRite Industries, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 27, 2025
- FDA report date
- Nov 26, 2025
Frequently asked
- Was DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, D… recalled?
- DermaRite Industries, LLC recalled DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, D… in Aug 2025 — an FDA Class II recall (D-0165-2026) because CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, D… recalled?
- Per the FDA enforcement record, the reason for recall D-0165-2026 was: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Is a recalled DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, D… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, D… are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — All lots on or before expiry date 08/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0165-2026.