Cephalexin Suspension (Ascend) - Stability Specification Failure (2025)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Ascend Laboratories, LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Ascend Laboratories, LLC is recalling Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: due to Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026