FDA Drug recall D-0538-2024
Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g ce…
- FDA Drug
- Class III
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class III recall of Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g ce… by Bryant Ranch Prepack, citing labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP eq….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0538-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-05-10 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bryant Ranch Prepack |
| Distribution | US |
Product
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 63629-8858-1.
Reason
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'
Identifiers
| ndc | 63629-8858-1 |
|---|---|
| code_info | Lot: 235287, 235629, 235805, 236292, 237022, 237308, 237748, Exp: 12/31/2025; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0538-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.