CUBICIN — Class I drug recall D-0001-2015
Terminated recall by Cubist Pharmaceuticals, Inc., reported 2014-10-08, distributed nationwide. Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
| Recall number | D-0001-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cubist Pharmaceuticals, Inc., Lexington, MA, United States |
| Recall initiated | 2014-08-01 |
| Classified | 2014-10-01 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2016-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | IL, TW |
| Quantity | 4,966,575 vials |
| Reason classes | foreign material, specification failure |
| NDC | 67919-0011-01 |
| Lot numbers | 081753F, 081803F, 081853F, 090103F, 090153F, 090303F, 090353F, 090403F, 090453F, 090503F, 100503F, 100553F, 100603F, 100653F, 100703F, 100753F, 100803F, 100853F, 100903F, 101303F, 110303F, 110353F, 110403F, 110453F, 110503F, 110603F, 110653F, 110703F, 120303F, 120353F, 120403F, 120453F, 120503F, 120553F, 120653F, 120703F, 140453F, 140603F, 140653F, 140703F and 61 more |
| Expiration dates | 2014-08, 2014-09, 2014-10, 2014-11, 2014-12, 2015-02, 2015-03, 2015-05, 2015-06, 2015-08, 2015-09, 2015-10, 2015-11, 2015-12, 2016-02, 2016-03, 2016-04, 2016-06 |
Product
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
Reason for recall
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
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-0001-2015. 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.