FDA Drug recall D-1406-2020
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,…
- FDA Drug
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,… by Lupin Pharmaceuticals, citing superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1406-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-02 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
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 # F802189, Exp 10/2020, F900240, Exp 1/2021 |
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-1406-2020%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.