Product: Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
Reason for recall: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis.    The individual impurity was identified to be Cephalexin Glucose Adduct.
Recall initiated: 20250523
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated