Cephalexin for Oral Suspension — Class II drug recall D-0263-2021
Terminated recall by Ascend Laboratories LLC, reported 2021-02-24, distributed nationwide. CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the spe
| Recall number | D-0263-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Parsippany, NJ, United States |
| Recall initiated | 2021-01-22 |
| Classified | 2021-02-18 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2022-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 14,205 |
| Reason classes | cgmp, specification failure |
| NDC | 67877-0544, 67877-0544-68, 67877-0544-88, 67877-0545, 67877-0545-68, 67877-0545-88 |
| Lot numbers | 19144841, 20141673 |
| Expiration dates | 2021-09, 2022-04 |
Product
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
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
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-0263-2021. 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.