Drug FDA Class III Ongoing Mislabeling
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
Bryant Ranch Prepack, Inc. Published Jun 12, 2024
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 40/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Bryant Ranch Prepack, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Affected products (1)
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
CEPHALEXIN · 156 bottles
NDC: 63629-9204, 63629-9204-1
Lot codes: 225541
Code info: Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025
Affected areas
Nationwide
Timeline
- InitiatedMay 10, 2024
- PublishedJun 12, 2024
- Recall number
- D-0536-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.