FDA Drug recall D-0648-2024
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21…
- FDA Drug
- Class II
- terminated
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21… by Lupin Pharmaceuticals, citing subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0648-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-08-21 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Identifiers
| ndc | 68180-405-01 |
|---|---|
| ndc | 68180-407-03 |
| ndc | 68180-407-04 |
| ndc | 68180-416-08 |
| ndc | 68180-416-11 |
| ndc | 68180-423-11 |
| ndc | 68180-423-08 |
| code_info | Lot #: F201517, Exp 11/30/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0648-2024%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.