Cubicin (Cubist) – Particulate Matter Contamination (2014)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Cubist Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Cubist Pharmaceuticals, Inc. is recalling CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manu due to Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 13, 2026