Cephalexin Suspension (Ascend Laboratories) – Impurity Issues (2020)
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, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054
Brand
Ascend Laboratories LLC
Lot Codes / Batch Numbers
Lot#: a) 19144340, 19144341, Exp AUG 2021, b) 20142226, 20142227, Exp MAY 2022
Products Sold
Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
Ascend Laboratories LLC is recalling Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC due to Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS . 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 Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
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