Ascend Cephalexin Oral Suspension Recalled for Impurity Specifications
Ascend Laboratories is recalling Cephalexin for Oral Suspension because it failed impurity and degradation specifications.
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 typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses, injuries, or fatalities, and the hazard is related to quality specifications rather than a known acute toxic event.
Plain-English summary
Ascend Laboratories LLC is recalling 29,317 bottles of Cephalexin for Oral Suspension, USP 250 mg per 5 mL (100 mL when mixed). The product is distributed nationwide and is manufactured by Alkem Laboratories, Ltd, in Mumbai, India.
The recall was initiated because the product failed impurity and degradation specifications. The affected product is identified by NDC 67877-545-88 and specific lot codes including 20141674, 20141675, 20141676, 20141677, and 20141678.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or further instructions.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 29,317
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 (5)
- 20141674
- 20141675
- 20141676
- 20141677
- 20141678
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 Impurity Specifications
FDA (Drugs) · 2025-06-18
- ModerateCephalexin Oral Suspension Recalled for Failed Impurities Specifications
FDA (Drugs) · 2025-06-18
- 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
- LowCephalexin for Oral Suspension Recalled for Back Label Error
FDA (Drugs) · 2024-06-12
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