The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0012-2021·Announced 2020-09-16

Teva Recalls Cephalexin Oral Suspension Due to CGMP Deviations

Teva Pharmaceuticals is recalling specific lots of Cephalexin for Oral Suspension because current Good Manufacturing Practice deviations may cause active ingredient levels to fall outside specification limits.

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, and the source text describes a theoretical possibility of specification deviations without reporting any specific illnesses, injuries, or hospitalizations, aligning with the criteria for a moderate severity score.

Plain-English summary

Teva Pharmaceuticals USA is recalling 103,940 bottles of Cephalexin for Oral Suspension, USP 125 mg per 5 mL. The affected products are available in 100 mL and 200 mL bottles for reconstitution and oral use only. The recall is due to current Good Manufacturing Practice (CGMP) deviations, which create a possibility that the active ingredient in some bottles may be above or below specification limits.

The recall covers specific lot numbers with expiration dates ranging from August 2020 to June 2021. These products were distributed nationwide in the United States and Puerto Rico. The recall number is D-0012-2021.

Consumers should check their medication for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on replacement medication.

The recalled product

Product
CEPHALEXIN (CEPHALEXIN)
Brand
CEPHALEXIN
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Antibiotic
Hazard
Affected units
103,940

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 #s: a) 30309820A
  • Exp. 08/2020
  • 30310000B
  • 30310001B
  • Exp. 10/2020
  • 30310096A Exp. 01/2021
  • 30310228A
  • Exp. 03/2021
  • 30310313A
  • Exp. 06/2021
  • b) 30309861A
  • 30310335A
  • Exp. 06/2021.

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 →

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