Cefixime for Oral Suspension USP — Class II drug recall D-0648-2024
Terminated recall by Lupin Pharmaceuticals Inc., reported 2024-09-04, distributed nationwide. Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stabil
| Recall number | D-0648-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2024-08-21 |
| Classified | 2024-08-26 |
| Reported by FDA | 2024-09-04 |
| Terminated | 2025-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 4,554 bottles |
| Reason classes | potency, specification failure |
| NDC | 68180-0405, 68180-0405-01, 68180-0407, 68180-0407-03, 68180-0407-04, 68180-0416, 68180-0416-08, 68180-0416-11, 68180-0423, 68180-0423-08, 68180-0423-11 |
| Lot numbers | F201517 |
| Expiration dates | 2024-11-30 |
Product
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Reason for recall
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
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-0648-2024. 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.