Suprax — Class III drug recall D-1186-2014
Terminated recall by Lupin Pharmaceuticals Inc., reported 2014-04-09, distributed nationwide. Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-
| Recall number | D-1186-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2014-01-27 |
| Classified | 2014-04-02 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2015-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 4,038 bottles |
| Reason classes | specification failure |
| NDC | 27437-0207-02 |
| Lot numbers | F300737, F300743 |
| Expiration dates | 2015-02-20 |
Product
Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.
Reason for recall
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
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-1186-2014. 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.