TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles recall — FDA D-0695-2026
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Complete FDA and NHTSA recall records dated in July 2026.
These records include useful source details for the selected month.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Lack of assurance of Sterility:
Lack of Assurance of Sterility
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Lack of Assurance of Sterility
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Elevated coliforms
Potential contamination with plastic material
Product may be contaminated with Clostridium botulinum.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.