Cephalexin oral suspension recalled for incorrect dose labeling
Bryant Ranch Prepack is recalling 61 bottles of Cephalexin for Oral Suspension due to a back label stating an incorrect dose amount—5g instead of 10g per bottle.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is a Class III recall with a labeling error—a documentation issue. No illnesses or injuries are reported. The actual product is correct; only the back label contains inaccurate dosage information.
Plain-English summary
Bryant Ranch Prepack, Inc. is recalling 61 bottles of Cephalexin for Oral Suspension, USP, 250mg/5mL nationwide due to a labeling error on the back label.
The back label incorrectly states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' when it should state 'Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g.' This discrepancy could cause patients to misunderstand the actual dose content of the product.
The recalled product includes lot numbers 235067 (expires 12/31/2025), 235289 (expires 11/30/2025), and 235290 (expires 12/31/2025). Consumers should stop using the product and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Bryant Ranch Prepack, Inc.
- Hazard
- Affected units
- 61
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 (5)
- Lot: 235067
- Exp 12/31/2025
- 235289
- Exp 11/30/2025
- 235290
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Bryant Ranch Prepack, Inc. 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 5 products in this recall →Related recalls
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