Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Accord Healthcare Daptomycin for Injection Recalled for Labeling Mixup

Agency Publication Date: January 13, 2023
Share:
Sign in to monitor this recall

Summary

Accord Healthcare, Inc. is recalling one lot of daptomycin (Daptomycin for Injection), a medication used to treat serious bacterial infections. The recall was issued because cartons labeled as containing 350 mg/vial actually contained vials with a 500 mg dose, leading to a risk that patients receive more medication than intended. The product was distributed nationwide to pharmacies and hospitals. No injuries or illnesses have been reported to date.

Risk

Patients who receive 500 mg of daptomycin instead of the intended 350 mg dose are at risk for drug toxicity and severe side effects. This potency error could lead to significant health complications depending on the patient's condition.

What You Should Do

  1. The recalled product is Accord Healthcare Daptomycin for Injection 350 mg/vial, packaged in single-dose vial cartons identified by NDC 16729-0434-05 and Lot R2200232 with an expiration date of January 2025.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Daptomycin for Injection (350 mg/vial)
Variants: 350 mg/vial, Single-dose vial
Lot Numbers:
R2200232 (Exp. 01/2025)
NDC:
16729-0434-05

Cartons labeled as 350 mg/vial contain vials of 500 mg per vial.

Product Images

Image 1 โ€“ Carton Daptomycin for Injection 350 mg/vial

Image 1 โ€“ Carton Daptomycin for Injection 350 mg/vial

Image 2 โ€“ Vial โ€“ Daptomycin for Injection 500mg/vial

Image 2 โ€“ Vial โ€“ Daptomycin for Injection 500mg/vial

Image 3 - Vial โ€“ Daptomycin for Injection 500mg/vial

Image 3 - Vial โ€“ Daptomycin for Injection 500mg/vial

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91228
Status: Resolved
Manufacturer: Accord Healthcare, Inc.
Sold By: pharmacies; hospitals
Manufactured In: India, United States
Units Affected: Unknown
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.