Drug FDA Class III Ongoing Mislabeling
Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1.
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: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Affected products (1)
Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1.
CEPHALEXIN · 61 Bottles
NDC: 63629-9207, 63629-9207-1
Lot codes: 235067
Code info: Lot: 235067, Exp 12/31/2025; 235289, Exp 11/30/2025; 235290, Exp 12/31/2025
Affected areas
Nationwide
Timeline
- InitiatedMay 10, 2024
- PublishedJun 12, 2024
- Recall number
- D-0540-2024
- 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.