Class II · Moderate risk
Daptomycin
CGMP Deviations
Daptomycin (Daptomycin in Sodium Chloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.
Affected NDC
0338-0718-12
Compare with the code on your package — it is the most precise check available.
Drug: Daptomycin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Daptomycin in Sodium Chloride NDC 00338-0718 |
DAPTOMYCIN 1000 mg/100mL | Injection, Solution Intravenous |
Baxter Healthcare Corporation | Rx |
- Recalling firm
- Baxter Healthcare Corporation
- NDC code
- 0338-0718-12
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0821-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Daptomycin recalls
See all
Class II · Moderate risk
Daptomycin for Injection 500 mg per vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin for Injection 350 mg/vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin
Lack of sterility assurance
Class II · Moderate risk
Daptomycin
Lack of sterility assurance
Other recalls by Baxter Healthcare Corporation
All 2026 recalls
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Class II · Moderate risk
Vasopressin
CGMP Deviations
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.