Cefdinir for Oral Suspension USP — Class II drug recall D-0375-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-01-16, distributed nationwide. CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
| Recall number | D-0375-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-01-02 |
| Classified | 2019-01-15 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2020-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 287,784 bottles |
| Reason classes | cgmp |
| 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 | F700327, F700328, F700329, F700330, F700392, F700393, F700544, F700545, F700546, F700547, F700664, F700668, F700669, F700670, F700958, F700967, F701106, F701107, F701108, F701109 |
| Expiration dates | 2019-01-20, 2019-03-20, 2019-04-20, 2019-05-20 |
Product
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Reason for recall
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
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-0375-2019. 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.