Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0178-2021·Announced 2021-01-06

Ascend Cephalexin Oral Suspension Recalled for Impurity Specifications

Ascend Laboratories is recalling Cephalexin for Oral Suspension because it failed impurity and degradation specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: impurity
degradation
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 →

Same brand · CEPHALEXIN

Moderate
Cephalexin Oral Suspension Recalled for Failed Impurity Specifications
FDA (Drugs) · 2025-06-18
Moderate
Cephalexin Oral Suspension Recalled for Failed Impurities Specifications
FDA (Drugs) · 2025-06-18
Moderate
Cephalexin oral suspension recalled for incorrect label dosage amount
FDA (Drugs) · 2024-06-12
Moderate
Cephalexin Oral Suspension Recalled for Incorrect Dosage Label
FDA (Drugs) · 2024-06-12
Moderate
Cephalexin oral suspension recalled for incorrect dose labeling
FDA (Drugs) · 2024-06-12

Same manufacturer · Ascend Laboratories LLC

See all →

Low
Dabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
Low
Dabigatran Etexilate Capsules Recalled Over Impurity Specification Failure
FDA (Drugs) · 2026-08-05
Low
Dabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
Moderate
Drug Recall: Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories
FDA (Drugs) · 2026-07-29
Moderate
FDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test
FDA (Drugs) · 2026-07-29

Same hazard · impurity