Cefixime for Oral Suspension USP — Class II drug recall D-1252-2020
Terminated recall by Lupin Pharmaceuticals Inc., reported 2020-04-29, distributed nationwide. Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
| Recall number | D-1252-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2020-04-15 |
| Classified | 2020-04-23 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2021-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 4,518 bottles |
| Reason classes | potency, specification failure |
| NDC | 68180-0405, 68180-0405-01, 68180-0407, 68180-0407-03, 68180-0407-04, 68180-0416, 68180-0416-08, 68180-0416-11, 68180-0423, 68180-0423-08, 68180-0423-11 |
| Lot numbers | F800779 |
| Expiration dates | 2020-04 |
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 for recall
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
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-1252-2020. 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.