CLASS I Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report
Cubicin (daptomycin for injection) 500 mg, For Intravenous Use Only recalled
Cubist Pharmaceuticals is recalling Cubicin (daptomycin for injection) 500 mg, For Intravenous Use Only, distributed nationwide in the US. The recall was initiated on 8 Aug 2014 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0229-2015
- FDA event ID
- 67180
- Recalling firm
- Cubist Pharmaceuticals, Lexington, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 Aug 2014
- FDA classified
- 30 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Aug 2014 | Recall initiated by company | |
| 30 Oct 2014 | Classified by FDA | +83 days |
| 5 Nov 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Which lots are affected?
Lot #'s: CDC203, Exp 12/2015; CDC207, Exp 01/2016; CDC213, Exp 02/2016; CDC217, Exp 03/2016; CDC226, Exp 04/2016; CDC234, CDC235, Exp 05/2016; CDC243, CDC246, Exp 07/2016.
Where was it sold?
Nationwide and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cubist Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cubicin (daptomycin for injection), 500 mg single-use vial recalled | Cubist Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Cubicin (daptomycin for injection), 500 mg single-use vial recalled | Cubist Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Cubicin (daptomycin for injection) recalled by Cubist Pharmaceuticals | Cubist Pharmaceuticals | Particulate Matter | Nationwide |
Other Cubicin (daptomycin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cubicin (daptomycin for injection), 500 mg per vial recalled | Merck Sharp & Dohme | Particulate Matter | Nationwide |
| Drug | CLASS II | Cubicin (daptomycin) in NS, Packaged as a) 350MG recalled | Sentara Enterprises | Sterility | NC, VA |
| Drug | CLASS I | Cubicin (daptomycin for injection), 500 mg single-use vial recalled | Cubist Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Cubicin (daptomycin for injection), 500 mg single-use vial recalled | Cubist Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Cubicin (daptomycin for injection) recalled by Cubist Pharmaceuticals | Cubist Pharmaceuticals | Particulate Matter | Nationwide |