Class II · Moderate risk
Daptomycin
CGMP Deviations
Is Daptomycin recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Daptomycin (19 total). Check the affected lots below.
Most common reason: Particulate / foreign matter (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Daptomycin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Daptomycin recalls in 2026
2 initiated in 2026, 19 in total — newest first
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Daptomycin for Injection 500 mg per vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin for Injection 350 mg/vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin
Lack of sterility assurance
Class II · Moderate risk
Daptomycin
Lack of sterility assurance
Class I · High risk
Daptomycin for Injection 350 mg/vial 1 Single-dose vial
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter: Identified as Glass Particles
Class I · High risk
Daptomycin for Injection
Presence of Particulate Matter
Class II · Moderate risk
Daptomycin
Lack Of Processing Controls
Class II · Moderate risk
Daptomycin for Injection
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Class II · Moderate risk
Daptomycin 650 mg in 50 mL 0.9% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
CUBICIN (daptomycin)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Daptomycin various strengths in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Daptomycin active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter; Glass particulates observed in vials
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