FDA Drug recall D-0469-2025
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distri…
- FDA Drug
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distri… by Ascend Laboratories, citing failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual imp….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0469-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-23 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Reason
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Identifiers
| ndc | 67877-544-88 |
|---|---|
| ndc | 67877-544-68 |
| ndc | 67877-545-88 |
| ndc | 67877-545-68 |
| code_info | Lot #: 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date…Lot #: 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date: 11/30/2025; Lot 24140027, Exp Date: 12/31/2025; 24144282, Exp Date: 10/31/2026 |
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-0469-2025%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.