FDA Drug recall D-1252-2020
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc
- FDA Drug
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc by Lupin Pharmaceuticals, citing subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1252-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-15 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
Reason
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Identifiers
| ndc | 68180-405-01 |
|---|---|
| ndc | 68180-407-03 |
| ndc | 68180-407-04 |
| ndc | 68180-416-08 |
| ndc | 68180-416-11 |
| ndc | 68180-423-11 |
| ndc | 68180-423-08 |
| code_info | Lot #: F800779, Expiry 4/2020 |
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-1252-2020%22
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