The Recall Desk
LowFDA (Drugs)·D-0539-2024·Announced 2024-06-12

Cephalexin for Oral Suspension Recalled for Back Label Error

Cephalexin for Oral Suspension is being recalled due to a back label error. The label states 'Each contains' instead of 'Each Bottle contains,' affecting 190 bottles distributed nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: FDA Class III recall for a minor labeling discrepancy with no reported health or safety risks. The error is a grammatical omission on the back label, representing a documentation issue rather than a product quality defect.

Plain-English summary

Bryant Ranch Prepack, Inc. is recalling Cephalexin for Oral Suspension, USP, 250mg per 5mL, in 100mL bottles. This is a prescription antibiotic used to treat bacterial infections. A total of 190 bottles have been recalled and distributed nationwide.

The back label of the affected product contains a labeling error. The label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of 'Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g.' This grammatical discrepancy may create confusion about which container the dosage statement refers to. Affected lot numbers include 235288, 235294, 235368, 235806, 236058, 236138, 236139, 236351, 236490, 236757, 236877 (with expiration date 11/30/2025) and 236758, 236762, 237254, 237349, 237401, 237807 (with expiration date 12/31/2025).

Consumers and healthcare providers who possess this product should verify their stock against the lot numbers listed. The product was distributed nationwide. For further information, contact Bryant Ranch Prepack, Inc.

The recalled product

Product
CEPHALEXIN (CEPHALEXIN)
Brand
CEPHALEXIN
Manufacturer
Bryant Ranch Prepack, Inc.
Hazard
  • mis-labeling

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 (19)

  • Lot: 235288
  • 235294
  • 235368
  • 235806
  • 236058
  • 236138
  • 236139
  • 236351
  • 236490
  • 236757
  • 236877
  • Exp:11/30/2025
  • 236758
  • 236762
  • 237254
  • 237349
  • 237401
  • 237807
  • Exp: 12/31/2025.

Distribution

Distributed nationwide across the United States.