CLASS II ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg recalled
Baxter Healthcare is recalling Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per (10 mg/mL), 500 mg total, in, distributed nationwide in the US. The recall was initiated on 6 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0807-2026
- FDA event ID
- 99500
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Aug 2026
- FDA classified
- 28 Aug 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Aug 2026 | Recall initiated by company | |
| 28 Aug 2026 | Classified by FDA | +22 days |
| 9 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24.
Where it was distributed
US Nationwide; Puerto Rico; and Chile.
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # NC188692, Exp Date: 11/22/2027.
Where was it sold?
US Nationwide; Puerto Rico; and Chile.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 99500This product is part of a recall event; the main page for the event is Clindamycin Injection USP in 5% Dextrose, 900 mg recalled.
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Other Daptomycin recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg recalled | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Daptomycin for Injection 350 mg/vial recalled by Accord HealthcareDaptomycin | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Daptomycin for Injection 500 mg per vial, Single-dose vial recalledDaptomycin | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS I | Daptomycin for Injection 350 mg/vial-dose vial recalled | Accord Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Daptomycin for Injection, 500 mg/vial, Single-Dose Vial recalledDaptomycin | Mylan Institutional | Particulate Matter | Nationwide |