The Recall Desk
ModerateFDA (Drugs)·D-0179-2021·Announced 2021-01-06

Ascend Cephalexin Oral Suspension Recalled for Impurity Specification Failures

Ascend Laboratories is recalling Cephalexin for Oral Suspension because it failed impurity and degradation specifications. The recall covers 9,524 bottles distributed nationwide.

What this means for you

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, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses or injuries, and the hazard is related to impurity specifications rather than a high-risk pathogen or structural defect.

Plain-English summary

Ascend Laboratories LLC is recalling Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 200 mL bottles. The recall is due to the product failing impurity and degradation specifications. The affected product is manufactured by Alkem Laboratories, Ltd, Mumbai, India, and distributed by Ascend Laboratories, LLC in Parsippany, NJ.

The recall involves 9,524 bottles of the medication. The specific lot codes affected are 20141680, 20141681, and 20141759. The product was distributed nationwide. The NDC codes for the recalled product are 67877-545-68 and 67877-544-68.

Consumers and healthcare providers should check their inventory for these specific lot codes. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this specific product.

The recalled product

Product
CEPHALEXIN (CEPHALEXIN)
Brand
CEPHALEXIN
Manufacturer
Ascend Laboratories LLC
Category
Drug — Antibiotic
Hazard
Affected units
9,524

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)

  • 20141680
  • 20141681
  • 20141759

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 →

Related recalls

Same brand · CEPHALEXIN

Same manufacturer · Ascend Laboratories LLC

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Same hazard · impurity

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