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.
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 1/5 (Low).
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
- Affected units
- 156
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.
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
Same brand · CEPHALEXIN
- ModerateCephalexin Oral Suspension Recalled for Failed Impurities Specifications
FDA (Drugs) · 2025-06-18
- ModerateCephalexin Oral Suspension Recalled for Failed Impurity Specifications
FDA (Drugs) · 2025-06-18
- ModerateCephalexin oral suspension recalled for incorrect label dosage amount
FDA (Drugs) · 2024-06-12
- ModerateCephalexin Oral Suspension Recalled for Incorrect Dosage Label
FDA (Drugs) · 2024-06-12
- ModerateCephalexin oral suspension recalled for incorrect dose labeling
FDA (Drugs) · 2024-06-12
Same manufacturer · Bryant Ranch Prepack, Inc.
See all →- LowCephalexin for Oral Suspension Recalled for Back Label Error
FDA (Drugs) · 2024-06-12
- ModerateLidocaine Patch 5% Recalled for Typographical Error on Label
FDA (Drugs) · 2023-05-10
- CriticalMorphine Sulfate Extended-Release Tablets Recalled for Strength Label Mix-up
FDA (Drugs) · 2022-07-20
- SevereMorphine Sulfate Tablets Recalled for Label Mix-up Dosage Error
FDA (Drugs) · 2022-07-20
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- ModerateBryant Ranch Recalls Venlafaxine Tablets Due to Labeling Error
FDA (Drugs) · 2016-05-11
- ModerateTeva Recalls Cephalexin Oral Suspension Due to CGMP Deviations
FDA (Drugs) · 2020-09-16
- SevereMethocarbamol Tablets Mislabeled with Incorrect Strength
FDA (Drugs) · 2021-11-10
- ModerateLupin Recalls Cephalexin Oral Suspension Due to Missing Manufacturing Records
FDA (Drugs) · 2019-01-23
- SevereSpironolactone Tablets Recalled Due to Potential Labeling Error
FDA (Drugs) · 2021-03-24
- ModeratePrecision Dose Recalls Carbamazepine Oral Suspension Due to Carton Labeling Error
FDA (Drugs) · 2017-08-09