FDA Drug recall D-0518-2024
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimor…
- FDA Drug
- Class II
- terminated
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimor… by Lupin Pharmaceuticals, citing defective container: lack of seal integrity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0518-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-05-08 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
Reason
Defective container: lack of seal integrity.
Identifiers
| ndc | 68180-722-20 |
|---|---|
| ndc | 68180-722-10 |
| ndc | 68180-722-04 |
| ndc | 68180-722-05 |
| ndc | 68180-723-20 |
| ndc | 68180-723-10 |
| ndc | 68180-723-04 |
| ndc | 68180-723-05 |
| code_info | Lot #F305184, F305185, F305186, Exp 7/31/ 2025 |
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-0518-2024%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.