Cefdinir for Oral Suspension USP 125 mg/5 mL — Class II drug recall D-0497-2024
Terminated recall by Lupin Pharmaceuticals Inc., reported 2024-05-22, distributed nationwide. Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
| Recall number | D-0497-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2024-04-24 |
| Classified | 2024-05-14 |
| Reported by FDA | 2024-05-22 |
| Terminated | 2025-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 17,040 bottles |
| Reason classes | foreign material |
| NDC | 68180-0722, 68180-0722-04, 68180-0722-05, 68180-0722-10, 68180-0722-20, 68180-0723, 68180-0723-04, 68180-0723-05, 68180-0723-10, 68180-0723-20 |
| Lot numbers | F305292 |
| Expiration dates | 2025-08-30 |
Product
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
Reason for recall
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
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-0497-2024. 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.