Cephalexin for Oral Suspension — Class II drug recall D-0468-2025
Ongoing recall by Ascend Laboratories, LLC, reported 2025-06-18, distributed nationwide. Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substa
| Recall number | D-0468-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Parsippany, NJ, United States |
| Recall initiated | 2025-05-23 |
| Classified | 2025-06-12 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 48,936 |
| Reason classes | specification failure |
| NDC | 67877-0544, 67877-0544-68, 67877-0544-88, 67877-0545, 67877-0545-68, 67877-0545-88 |
| Lot numbers | 11/302025, 23141828, 23141829, 23142342, 23142708, 23144035, 23144270, 24140026 |
| Expiration dates | 2025-05-31, 2025-06-30, 2025-07-31, 2025-10-31, 2025-12-31 |
Product
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
Reason for recall
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.
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-0468-2025. 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.