Ascend Recalls Cephalexin Oral Suspension Due to CGMP Deviations
Ascend Laboratories LLC is recalling Cephalexin for Oral Suspension due to CGMP deviations involving unidentified impurities.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is generally considered a moderate risk. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a CGMP deviation regarding impurity levels rather than a known high-risk pathogen or structural defect.
Plain-English summary
Ascend Laboratories LLC is recalling 23,436 bottles of Cephalexin for Oral Suspension, USP 250 mg per 5 mL (200 mL when mixed). The product is distributed nationwide in the USA and is manufactured by Alkem Laboratories, Ltd, Mumbai, India.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, individual unidentified impurities in the product were found at levels higher than the specification limit.
Consumers should check their medication for the following lot numbers and expiration dates: 19141869 and 19141870 (EXP 3/2021); 19142762 (EXP 5/2021); and 19143826, 19143923, 19143941, and 19143954 (EXP 7/2021). If you have this product, you should stop using it and contact your healthcare provider or pharmacist for guidance.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Antibiotic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #: 19141869
- 19141870
- EXP 3/2021
- 19142762
- EXP 5/2021
- 19143826
- 19143923
- 19143941
- 19143954 EXP 7/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ascend Laboratories LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · CEPHALEXIN
- ModerateCephalexin Oral Suspension Recalled for Failed Impurities Specifications
FDA (Drugs) · 2025-06-18
- ModerateCephalexin Oral Suspension Recalled for Failed Impurity Specifications
FDA (Drugs) · 2025-06-18
- ModerateCephalexin oral suspension recalled for incorrect label dosage amount
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- LowCephalexin Oral Suspension Recalled for Incorrect Labeling and Missing Dosage Information
FDA (Drugs) · 2024-06-12
- ModerateCephalexin Oral Suspension Recalled for Incorrect Dosage Label
FDA (Drugs) · 2024-06-12
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