The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0468-2025·Announced 2025-06-18

Cephalexin Oral Suspension Recalled for Failed Impurity Specifications

Ascend Laboratories is recalling Cephalexin for Oral Suspension due to failed impurity specifications identified during stability testing. An out-of-specification result for Cephalexin Glucose Adduct was observed at six months.

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: This is an FDA Class II recall for a failed impurity specification with no reported illnesses or injuries. The hazard is related to out-of-specification degradation impurities identified during stability testing, which represents a precautionary quality-control issue rather than an active harm event.

Plain-English summary

Ascend Laboratories, LLC is recalling Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL bottles (NDC 67877-544-88) distributed nationwide. The recall was initiated after an out-of-specification result was observed in the related substance test during stability analysis at the sixth month. The individual impurity identified was Cephalexin Glucose Adduct.

The affected product includes lot numbers 23141828, 23141829, 23142342, 23142708, 23144035, 23144270, and 24140026, with expiration dates ranging from May 31, 2025, through December 31, 2025. A total of 48,936 bottles were distributed. The product is manufactured by Alkem Laboratories Ltd., India, and distributed by Ascend Laboratories, LLC, Parsippany, NJ.

Patients currently taking this medication should consult their healthcare provider or pharmacist. Do not stop taking the medication without medical guidance.

The recalled product

Product
CEPHALEXIN (CEPHALEXIN)
Brand
CEPHALEXIN
Manufacturer
Ascend Laboratories, LLC
Category
Drug — Oral Suspension / 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 (13)

  • Lot #: 23141828
  • 23141829
  • Exp Date: 5/31/2025
  • 23142342
  • Exp Date: 6/30/2025
  • 23142708
  • Exp Date: 7/31/2025
  • 23144035
  • Exp Date: 10/31/2025
  • 23144270
  • Exp Date: 11/302025
  • 24140026
  • Exp Date: 12/31/2025

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 →

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