The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0013-2021·Announced 2020-09-16

Teva Recalls Cephalexin Oral Suspension Due to CGMP Deviations

Teva Pharmaceuticals is recalling 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, which the rubric associates with moderate severity when no specific hospitalizations or injuries are reported, and the hazard is a potential deviation in active ingredient levels.

Plain-English summary

Teva Pharmaceuticals USA is recalling Cephalexin for Oral Suspension, USP 250 mg per 5 mL, in 100 mL and 200 mL bottles. The recall involves 1,467,535 bottles distributed nationwide in the U.S. and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. These deviations create a possibility that some bottles in the affected lots may contain the active ingredient at levels above or below the established specification limits.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. Affected products should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
CEPHALEXIN (CEPHALEXIN)
Brand
CEPHALEXIN
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Antibiotic
Hazard
Affected units
1,467,535

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 (20)

  • Lot #s: a) 30309862A
  • 30309863A
  • Exp. 08/2020
  • 30309928A
  • 30309929A
  • Exp. 09/2020
  • 30310029A
  • 30310030A
  • 30310033A
  • 30310034A
  • Exp. 10/2020
  • 30310035A
  • 30310079A
  • 30310080A
  • 30310081A
  • Exp. 11/2020
  • 30310134A
  • 30310135A
  • Exp. 01/2021
  • 30310182A

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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