Cephalexin Oral Suspension Recalled for Incorrect Labeling and Missing Dosage Information
Bryant Ranch Prepack is recalling Cephalexin oral suspension bottles due to incorrect labeling that states tablet information instead of liquid suspension details and omits the total dose per bottle.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The recall addresses a labeling error that could create confusion about medication dosage form, but no actual harm has been documented. Class III recalls involving labeling and documentation issues typically receive Low severity scores.
Plain-English summary
Bryant Ranch Prepack, Inc. is recalling Cephalexin oral suspension, 125 mg per 5 mL, with national distribution. The recall covers 156 bottles with lot numbers 225541, 226866, 227369, 227519, 229845, 231422, and 234889, expiring March 31, 2025.
The product labels contain multiple errors. The front label incorrectly states '100 Tablets' instead of '100 ml'. The back label incorrectly states 'Each Tablet contains' instead of 'Each Bottle contains'. Additionally, the label fails to list the total dose per bottle, which should be 2.5 g.
Patients and healthcare providers who have affected bottles should verify the lot number and expiration date. If an affected lot is identified, consult a pharmacist or healthcare provider for instructions on obtaining a correctly labeled replacement.
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 (8)
- Lot:225541
- 226866
- 227369
- 227519
- 229845
- 231422
- 234889
- Exp: 03/31/2025
Distribution
Distributed nationwide across the United States.
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