The Recall Desk
ModerateFDA (Drugs)·D-1566-2020·Announced 2020-09-16

Teva Recalls Cephalexin Oral Suspension Due to Low Potency

Teva Pharmaceuticals is recalling Cephalexin for Oral Suspension because test results showed the drug was below the required potency specification.

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, and the hazard is a sub-potent drug (low potency) without reported injuries or illnesses, which aligns with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Teva Pharmaceuticals USA is recalling 38,487 bottles of Cephalexin for Oral Suspension, USP 250 mg per 5 mL. The product is identified by Lot # 30310638A and has an expiration date of 02/2022. The recall was initiated because out-of-specification test results indicated that the drug's potency was below the required specification.

The affected product is a prescription-only oral suspension distributed nationwide in the U.S. and Puerto Rico. The specific NDC for the recalled item is 0093-4177-73.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or further instructions.

The recalled product

Product
CEPHALEXIN (CEPHALEXIN)
Brand
CEPHALEXIN
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Antibiotic
Hazard
Affected units
38,487

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 (2)

  • Lot #: 30310638A
  • Exp. 02/2022

UPCs (2)

  • 0300934175738
  • 0300934177732

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Teva Pharmaceuticals USA 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 3 products in this recall →

Related recalls

Same brand · CEPHALEXIN

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sub potent drug

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