Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0263-2021·Announced 2021-02-24

Ascend Recalls Cephalexin Oral Suspension Due to Impurity Levels

Ascend Laboratories is recalling Cephalexin for Oral Suspension because unidentified impurities were found at higher levels than allowed.

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 involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation involving impurities, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ascend Laboratories LLC is recalling 14,205 bottles of Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 mL. The product is distributed nationwide in the USA. The recall involves specific lots with expiration dates of 9/2021 and 4/2022.

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. The product is a prescription-only medication manufactured by Alkem Laboratories, Ltd, in India, and distributed by Ascend Laboratories, LLC in Parsippany, NJ.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternatives or replacement.

The recalled product

Product: CEPHALEXIN (CEPHALEXIN)
Brand: CEPHALEXIN
Manufacturer: Ascend Laboratories LLC
Category: Drug — Antibiotic
Hazard: impurity
cgmp-deviation

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 (3)

Lot # 19144841
Exp 9/2021
20141673 Exp 4/2022.

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
Low
Cephalexin for Oral Suspension Recalled for Back Label Error
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 label dosage amount
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 Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
Low
Dabigatran Etexilate Capsules Recalled Over Impurity Specification Failure
FDA (Drugs) · 2026-08-05
Moderate
Dabigatran Etexilate Capsules Recalled Over Impurity Test Failure
FDA (Drugs) · 2026-07-29
Moderate
Drug Recall: Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories
FDA (Drugs) · 2026-07-29

Same hazard · impurity