Ceftriaxone Sodium — Class III drug recall D-0955-2016
Terminated recall by Lupin Pharmaceuticals Inc., reported 2016-06-08, distributed nationwide. CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
| Recall number | D-0955-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2016-03-11 |
| Classified | 2016-06-02 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 741.171 kilograms |
| Reason classes | cgmp, specification failure |
| Lot numbers | 01/17, 02/18, 06/17, 10/17, B4000935, B4005178, B4008724, B4008727, B4008729, B4008730, B5001647, B5001648, B5001649 |
Product
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
Reason for recall
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
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-0955-2016. 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.