Cephalexin oral suspension recalled for incorrect label dosage amount
Bryant Ranch Prepack is recalling Cephalexin oral suspension (125mg/5mL) due to back label errors stating the dose as 2.5g instead of the correct 5g per bottle. No illnesses have been reported.
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 an FDA Class III labeling error involving incorrect dosage information with no reported illnesses or injuries. Per the severity rubric, FDA Class III recalls are typically scored 1 or 2, and minor labeling errors without reported harm are classified as Moderate (score 2).
Plain-English summary
Bryant Ranch Prepack, Inc. is recalling Cephalexin for Oral Suspension, USP, 125mg per 5mL in 200mL bottles due to labeling errors affecting the product's dosage information.
The back label of the affected bottles states 'Each contains: cephalexin monohydrate, USP equivalent to 2.5g' when it should state 'Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g.' This discrepancy could affect how healthcare providers or patients understand the dosage of the medication.
The recall affects lot 234892 with an expiration date of 02/28/2025, distributed nationwide in the United States. The product is manufactured by Alkem Laboratories Ltd and relabeled by Bryant Ranch Prepack, Inc. of Burbank, California. Consumers who have received affected bottles should contact their healthcare provider or pharmacist for guidance. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Bryant Ranch Prepack, Inc.
- Category
- Drug — Oral Suspension
- Affected units
- 6
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 (2)
- Lot:234892
- Exp:02/28/2025.
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.
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