Class II · Moderate risk
DermaSarra
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Kapsin Ointment
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363
Drug: Camphor
- Recalling firm
- Apipharma
- Origin
- N/A, Croatia
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0376-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Camphor recalls
See all
Class I · High risk
DermaSarra
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class II · Moderate risk
Parche Leon Pain Relieving Hot Patch
cGMP Deviations
Class II · Moderate risk
Absorbine Jr Pain Relieving Knee Patch
cGMP Deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Other recalls by Apipharma
All 2025 recalls
Class II · Moderate risk
Hemopropin Ointment
CGMP Deviations
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