CLASS I Drug recall · Reported 18 Jun 2014 · FDA Enforcement Report
Cubicin (daptomycin for injection), 500 mg single-use vial recalled
Cubist Pharmaceuticals is recalling Cubicin (daptomycin for injection), 500 mg single-use vial, distributed nationwide in the US. The recall was initiated on 17 Apr 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-1382-2014
- FDA event ID
- 68025
- Recalling firm
- Cubist Pharmaceuticals, Lexington, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Apr 2014
- FDA classified
- 12 Jun 2014
- Reported
- 18 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Apr 2014 | Recall initiated by company | |
| 12 Jun 2014 | Classified by FDA | +56 days |
| 18 Jun 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: Customer complaint stating that one vial contained a glass shard.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Which lots are affected?
Lot #: 280453F, Exp 04/16
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, For Intravenous Use Only 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, For Intravenous Use Only 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 |