Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Health...
FDA Drug Recall #D-0131-2023 — Class I — November 29, 2022
Recall Summary
| Recall Number | D-0131-2023 |
| Classification | Class I — Serious risk |
| Date Initiated | November 29, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Accord Healthcare, Inc. |
| Location | Durham, NC |
| Product Type | Drugs |
| Quantity | Unknown |
Product Description
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
Reason for Recall
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Distribution Pattern
Nationwide within the United States
Lot / Code Information
Lot: R2200232 Exp. 01/2025
Other Recalls from Accord Healthcare, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0006-2026 | Class II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.08... | Sep 16, 2025 |
| D-0521-2025 | Class II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1... | Jun 20, 2025 |
| D-0520-2025 | Class II | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05... | Jun 20, 2025 |
| D-0518-2025 | Class II | Levothyroxine Sodium Tablets, USP, 25 mcg (0.02... | Jun 20, 2025 |
| D-0522-2025 | Class II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.1... | Jun 20, 2025 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.