Cephalexin for Oral Suspension — Class III drug recall D-0538-2024
Ongoing recall by Bryant Ranch Prepack, Inc., reported 2024-06-12, distributed nationwide. Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent t
| Recall number | D-0538-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bryant Ranch Prepack, Inc., Burbank, CA, United States |
| Recall initiated | 2024-05-10 |
| Classified | 2024-06-04 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 104 bottles |
| Reason classes | labeling |
| NDC | 63629-8858, 63629-8858-01 |
| Lot numbers | 235287, 235629, 235805, 236292, 237022, 237308, 237748 |
| Expiration dates | 2025-12-31 |
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 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'
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0538-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.