Use caution Drug recall · FDA · Published October 19, 2021

Merck Cubicin 500mg Injection Recall: Glass Particles Hazard

Merck recalls Cubicin 500mg single-dose vials due to glass particles. This could cause serious injury during injection. Affected units have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0093-2022Drug Merck ›

Use caution until it’s fixed

Presence of Particulate Matter: Identified as Glass Particles

Take action

Contact the company

Recalling firmMERCK SHARP & DOHME CORP1 Merck Dr · Whitehouse Station, NJ 08889-3400

✎ GovInfoNow plain-language explainer

Merck is recalling Cubicin (daptomycin) 500mg single-dose vials because they contain glass particles. This hazard could cause serious injury during injection. The recall affects specific lot numbers with expiration dates. Read more at govinfonow.com/recall/35643-merck-cubicin-500mg-injection-recall-glass-particles-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/35643-merck-cubicin-500mg-injection-recall-glass-particles-hazard · Updated August 18, 2026 · FDA enforcement record: FDA #D-0093-2022

Cite this page

“Merck Cubicin 500mg Injection Recall: Glass Particles Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35643-merck-cubicin-500mg-injection-recall-glass-particles-hazard. Based on FDA recall #D-0093-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0093-2022%22&limit=1).

Merck Sharp & Dohme Corp. recalled Cubicin (daptomycin for injection), 500 mg per vial, due to the presence of glass particles, according to the FDA. The agency announced the Class I recall on Oct. 19, 2021. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Merck
Product: Cubicin (daptomycin for injection)
Strength/Format: 500 mg per vial, Single-dose vial
NDC: 67919-011-01
Lot #: 934778
Exp. Date: Jun 2022
Quantity: 76,163 vials

The hazard

The recall addresses the presence of particulate matter identified as glass particles in the drug vials. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show Merck Sharp & Dohme Corp. has one other recall on record since 2022-03-31, specifically the Janumet Recall on 2022-03-31 involving stainless steel particulates. Other recent recalls of similar products include Fresenius Kabi Tyenne Injection Recall (2026-08-10) and Merck Noxafil Powdermix Recall (2025-12-12).

How to tell if you have this one

Check for Cubicin 500mg single-dose vials with lot number 934778 and expiration date June 2022. The product is only available by prescription.

Brand
Merck
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Vial Details
Verify the lot number and expiration date on the vial label to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Oct 19, 2021Firm started the recall
Nov 3, 2021FDA classified it Class I
Nov 10, 2021Published in FDA’s Enforcement Report
Jul 25, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this product?

Check the lot number and expiration date. If it matches the recalled batch (lot 934778, exp. Jun 2022), stop using it and contact your healthcare provider.

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Link to this recall

<a href="https://govinfonow.com/recall/35643-merck-cubicin-500mg-injection-recall-glass-particles-hazard">Merck Cubicin 500mg Injection Recall: Glass Particles Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0093-2022 (October 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0093-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.