Biomed Laboratories, Llc.: Tychasis Coats Aloe Lotion (allantoin 0.5%)

Recalling firm
BioMed Laboratories, LLC.
Product
Tychasis Coats Aloe Lotion (Allantoin 0.5%) packaged in a)0.5 oz, b)8 oz (NDC 70211-704-08), and c)33 oz (NDC 70211-704-33) bottles, Manufactured for: Tychasis Corporation, Dallas, TX 75227. There is no NDC for the 0.5 oz given that it is a sample size used as a professional sample.
Reason
Failed Stability Specifications: OOS stability results included viscosity and appearance results that did not align with the established specifications.
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-10-15
Status
Ongoing
Areas affected
TX
Distribution
TX only

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/1946a36b-e314-4cb5-ba82-e93269afeca3