CUBICIN — Class I drug recall D-0229-2015
Terminated recall by Cubist Pharmaceuticals, Inc., reported 2014-11-05, distributed nationwide. Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of t
| Recall number | D-0229-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cubist Pharmaceuticals, Inc., Lexington, MA, United States |
| Recall initiated | 2014-08-08 |
| Classified | 2014-10-30 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2016-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 371,879 vials |
| Reason classes | specification failure |
| NDC | 67919-0011-01 |
| Lot numbers | CDC203, CDC207, CDC213, CDC217, CDC226, CDC234, CDC235, CDC243, CDC246 |
| Expiration dates | 2015-12, 2016-01, 2016-02, 2016-03, 2016-04, 2016-05, 2016-07 |
Product
CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01
Reason for recall
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
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-0229-2015. 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.