The Recall Desk
ModerateFDA (Drugs)·D-0538-2024·Announced 2024-06-12

Cephalexin Oral Suspension Recalled for Incorrect Dosage Label

Bryant Ranch Prepack is recalling Cephalexin oral suspension because the back label incorrectly states the bottle contains 5g instead of 10g. No illnesses have been reported.

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: FDA Class III recalls are typically scored 1 or 2 per the rubric. This labeling error involving incorrect dosage information qualifies as a 'minor labeling error,' and no illnesses have been reported, supporting a Moderate (2) classification.

Plain-English summary

Bryant Ranch Prepack, Inc. is recalling Cephalexin for Oral Suspension, USP 250mg/5mL (lot numbers 235287, 235629, 235805, 236292, 237022, 237308, 237748, expiring 12/31/2025). The product was distributed nationwide in the USA.

The back label incorrectly states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' when the correct statement should be 'Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g.' This labeling discrepancy understates the actual dosage content of each bottle and could cause confusion among patients and healthcare providers.

No illnesses or adverse effects have been reported. Consumers should consult their healthcare provider or pharmacist if they have questions about the correct dosage.

The recalled product

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

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 (8)

  • Lot: 235287
  • 235629
  • 235805
  • 236292
  • 237022
  • 237308
  • 237748
  • Exp: 12/31/2025

Distribution

Distributed nationwide across the United States.