CLASS I Drug recall · Reported 10 Nov 2021 · FDA Enforcement Report
Cubicin (daptomycin for injection), 500 mg per vial recalled
Merck Sharp & Dohme is recalling Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, distributed nationwide in the US. The recall was initiated on 19 Oct 2021 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-0093-2022
- FDA event ID
- 88867
- Recalling firm
- Merck Sharp & Dohme, Whitehouse Station, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Oct 2021
- FDA classified
- 3 Nov 2021
- Reported
- 10 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Oct 2021 | Recall initiated by company | |
| 3 Nov 2021 | Classified by FDA | +15 days |
| 10 Nov 2021 | Published in enforcement report | +7 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: Identified as Glass Particles
Product as listed by the FDA
Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Identified as Glass Particles
Which lots are affected?
Lot #: 934778, Exp. Date Jun 2022
Where was it sold?
Nationwide within the United States
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.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Janumet (sitagliptin and metformin HCl) tablets recalledJanumet | Merck Sharp & Dohme | Particulate Matter | Nationwide |
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Other Cubicin (daptomycin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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), 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 |