The Recall Desk
ModerateFDA (Drugs)·D-0381-2023·Announced 2023-03-08

Daptomycin injection recalled due to manufacturing compliance deviations

Accord Healthcare recalls Daptomycin for Injection in the US, Puerto Rico, and Canada affecting 65,233 vials due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall based on manufacturing compliance deviations with no reported illnesses, injuries, or hospitalizations. The recall is precautionary in nature and meets the rubric criterion for voluntary precautionary recalls.

Plain-English summary

Accord Healthcare, Inc. is recalling Daptomycin for Injection (350 mg/vial) distributed in the United States, Puerto Rico, and Canada. The recall affects 65,233 vials across multiple batches with expiration dates ranging from September 2023 to August 2025. The affected product is available in single-dose vials and in packages of 10 vials.

The recall follows an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations. The source does not specify the particular nature of these deviations or report any confirmed illnesses, injuries, or product-related adverse events.

Patients currently taking this medication should contact their healthcare provider if they have questions about their prescription. Healthcare providers and pharmacists should verify whether their inventory contains affected batch numbers and coordinate with their suppliers and Accord Healthcare for product replacement.

The recalled product

Product
DAPTOMYCIN (DAPTOMYCIN)
Brand
DAPTOMYCIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Injectable Antibiotic
Hazard
  • cgmp-violation
  • quality-control-issue

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Batches: a) R2101274
  • Exp. Date 9/30/2023
  • R2200161
  • Exp. Date 1/31/2025
  • R2200506
  • R2200697
  • Exp. Date 4/30/2025
  • R2201107
  • Exp. Date 7/31/2025
  • b) R2101471
  • R2200588
  • R2201333
  • R2201361
  • Exp. Date 8/31/2025

UPCs (4)

  • 0316729434058
  • 0316729434454
  • 316729434058
  • 316729434454

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · DAPTOMYCIN

Same category