The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0469-2025·Announced 2025-06-18

Cephalexin Oral Suspension Recalled for Failed Impurities Specifications

Ascend Laboratories is recalling Cephalexin for Oral Suspension due to an out-of-specification result in impurity testing that identified Cephalexin Glucose Adduct during stability analysis.

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 source documents an FDA Class II recall with an out-of-specification impurity finding detected during stability testing. No illnesses, hospitalizations, or injuries are reported, making this a precautionary quality issue without evidence of actual patient harm.

Plain-English summary

Ascend Laboratories, LLC is recalling Cephalexin for Oral Suspension, USP, 125 mg per 5 mL (200 mL bottles) distributed nationwide in the USA. The recall was initiated because an out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity identified was Cephalexin Glucose Adduct.

The affected product is manufactured by Alkem Laboratories Ltd., India, and distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. Affected lot numbers include: 23142343 (Exp Date 6/30/2025), 23143526 (Exp Date 9/30/2025), 23144036 (Exp Date 10/31/2025), 23144269 (Exp Date 11/30/2025), 24140027 (Exp Date 12/31/2025), and 24144282 (Exp Date 10/31/2026), with NDC 67877-544-68.

Patients who have this medication should consult their healthcare provider or pharmacist about whether to continue use or obtain a replacement. Healthcare providers should contact the recalling firm for additional information.

The recalled product

Product
CEPHALEXIN (CEPHALEXIN)
Brand
CEPHALEXIN
Manufacturer
Ascend Laboratories, LLC
Category
Drug — Oral Suspension
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 (12)

  • Lot #: 23142343
  • Exp Date: 6/30/2025
  • 23143526
  • Exp Date: 9/30/2025
  • 23144036
  • Exp Date: 10/31/2025
  • 23144269
  • Exp Date: 11/30/2025
  • Lot 24140027
  • Exp Date: 12/31/2025
  • 24144282
  • Exp Date: 10/31/2026

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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