Stop using now Drug recall · FDA · Published November 29, 2022

Accord Healthcare Recalls Daptomycin Due to Labeling Error

Accord Healthcare recalls specific lots of Daptomycin for Injection because cartons labeled as 350 mg/vial contained 500 mg/vials.

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

🇺🇸 FDA recall #D-0131-2023Drug Accord Healthcare ›

Stop using this now

Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial

Take action

Contact the company

Recalling firmAccord Healthcare, Inc.1009 Slater Rd Ste 210B · Durham, NC 27703-8446

✎ GovInfoNow plain-language explainer

Accord Healthcare, Inc. is recalling one lot of Daptomycin for Injection 350 mg/vial single-dose vials due to a labeling mixup. The cartons were labeled as containing 350 mg per vial, but they actually contained vials with 500 mg per vial. This discrepancy could lead to incorrect dosing if not identified before administration. Read more at govinfonow.com/recall/34210-accord-healthcare-recalls-daptomycin-due-to-labeling-error.

Source Summary by GovInfoNow · govinfonow.com/recall/34210-accord-healthcare-recalls-daptomycin-due-to-labeling-error · Updated October 10, 2026 · FDA enforcement record: FDA #D-0131-2023

Cite this page

“Accord Healthcare Recalls Daptomycin Due to Labeling Error.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34210-accord-healthcare-recalls-daptomycin-due-to-labeling-error. Based on FDA recall #D-0131-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0131-2023%22&limit=1).

Accord Healthcare, Inc. recalled Daptomycin for Injection 350 mg/vial due to a labeling mixup where cartons labeled as 350 mg contained vials of 500 mg per vial, according to the FDA on 2022-11-29.

How to tell if you have it

Brand: Accord Healthcare
Product: Daptomycin for Injection
NDC: 16729-0434-05
Lot: R2200232
Expiration Date: 01/2025

The hazard

The recall involves a labeling error where cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial.

Context

GovInfoNow's records show ACCORD HEALTHCARE, INC. has 16 other recalls on record since 2016-12-20. Other recent recalls of similar products include Slate Run Recalls Eptifibatide Injection Due to Labeling Error (2026-02-12), American Regent Levocarnitine Injection Recall: Missing Label Hazard (2026-04-16), and Baxter Healthcare Daptomycin Injection Recall: CGMP Deviations (2026-08-06).

How to tell if you have this one

Check if you have Daptomycin for Injection 350 mg/vial, Rx only, manufactured by Accord Healthcare, Inc. in Durham, NC. Specifically look for NDC 16729-0434-05 and Lot number R2200232 with an expiration date of 01/2025.

Brand
Accord Healthcare
Category
Drug

Based on the official FDA remedy

What to do — step by step

Verify Product Details
Check the NDC (16729-0434-05) and Lot number (R2200232) on the carton to confirm if it matches the recalled items.
Stop Using Recalled Items
Do not use any vials that match the recalled lot number, as they contain a different strength than labeled.
Contact Healthcare Provider
If you have already received this product, contact your healthcare provider or pharmacist immediately for guidance on next steps.

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 15 months after the firm started it.

Nov 29, 2022Firm started the recall
Jan 13, 2023FDA classified it Class I
Jan 25, 2023Published in FDA’s Enforcement Report
Feb 22, 2024FDA terminated the recall

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

Similar recalls

Other Accord Healthcare recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34210-accord-healthcare-recalls-daptomycin-due-to-labeling-error">Accord Healthcare Recalls Daptomycin Due to Labeling Error (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-0131-2023 (November 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0131-2023 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.