WhichRecall
Class IIReported 2025-06-18

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68

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.

Recall Number
D-0469-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-05-23
Reported
2025-06-18
Distribution
Nationwide in the USA.
Code Info
Lot #: 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date: 11/30/2025; Lot 24140027, Exp Date: 12/31/2025; 24144282, Exp Date: 10/31/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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