Ascend Laboratories — Class II drug recall D-0178-2021
Terminated recall by Ascend Laboratories LLC, reported 2021-01-06, distributed nationwide. Failed Impurity/Degradation Specifications
| Recall number | D-0178-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Parsippany, NJ, United States |
| Recall initiated | 2020-12-17 |
| Classified | 2020-12-30 |
| Reported by FDA | 2021-01-06 |
| Terminated | 2023-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 29,317 bottles |
| Reason classes | specification failure |
| NDC | 67877-0544, 67877-0544-68, 67877-0544-88, 67877-0545, 67877-0545-68, 67877-0545-88 |
Product
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
Reason for recall
Failed Impurity/Degradation Specifications
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-0178-2021. 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.