Home / drug / D-0468-2025 Class II Reported 2025-06-18
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 Recalled by Ascend Laboratories, LLC
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
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The individual impurity was identified to be Cephalexin Glucose Adduct.
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Recall Number D-0468-2025
Classification Class II
Status Ongoing
Category drug
Initiated 2025-05-23
Reported 2025-06-18
Distribution Nationwide in the USA.
Code Info Lot #: 23141828, 23141829, Exp Date: 5/31/2025; 23142342, Exp Date: 6/30/2025; 23142708, Exp Date: 7/31/2025; 23144035, Exp Date: 10/31/2025; 23144270, Exp Date: 11/302025; 24140026, Exp Date: 12/31/2025 Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer .