The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0264-2021·Announced 2021-02-24

Ascend Recalls Cephalexin Oral Suspension Due to CGMP Deviations

Ascend Laboratories LLC is recalling Cephalexin for Oral Suspension due to CGMP deviations involving unidentified impurities.

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 is generally considered a moderate risk. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a CGMP deviation regarding impurity levels rather than a known high-risk pathogen or structural defect.

Plain-English summary

Ascend Laboratories LLC is recalling 23,436 bottles of Cephalexin for Oral Suspension, USP 250 mg per 5 mL (200 mL when mixed). The product is distributed nationwide in the USA and is manufactured by Alkem Laboratories, Ltd, Mumbai, India.

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.

Consumers should check their medication for the following lot numbers and expiration dates: 19141869 and 19141870 (EXP 3/2021); 19142762 (EXP 5/2021); and 19143826, 19143923, 19143941, and 19143954 (EXP 7/2021). If you have this product, you should stop using it and contact your healthcare provider or pharmacist for guidance.

The recalled product

Product
CEPHALEXIN (CEPHALEXIN)
Brand
CEPHALEXIN
Manufacturer
Ascend Laboratories LLC
Category
Drug — 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 (9)

  • Lot #: 19141869
  • 19141870
  • EXP 3/2021
  • 19142762
  • EXP 5/2021
  • 19143826
  • 19143923
  • 19143941
  • 19143954 EXP 7/2021

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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