Cefdinir for Oral Suspension USP — Class II drug recall D-1406-2020
Terminated recall by Lupin Pharmaceuticals Inc., reported 2020-07-29, distributed nationwide. Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
| Recall number | D-1406-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2020-07-02 |
| Classified | 2020-07-23 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2021-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 35,928 bottles |
| Reason classes | potency, specification failure |
| 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 | F802189, F900240 |
| Expiration dates | 2020-10, 2021-01 |
Product
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
Reason for recall
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
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-1406-2020. 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.