Cefixime Capsules (Ascend) – Failed Specifications (2021)
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
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
Brand
Ascend Laboratories, LLC
Lot Codes / Batch Numbers
Lot #: 20140293, Exp Dec 2021, 20141525, 20141526, 20141527, Exp Mar 2022, 20143019, 20143020, 20143021, 20143022, Exp July 2022, 20144759, 20144760, 20144761, Exp Nov 22
Products Sold
Lot #: 20140293, Exp Dec 2021; 20141525, 20141526, 20141527, Exp Mar 2022; 20143019, 20143020, 20143021, 20143022, Exp July 2022; 20144759, 20144760, 20144761, Exp Nov 22
Ascend Laboratories, LLC is recalling Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumb due to Failed impurities/degradation specifications. 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
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