FDA Drug recall D-0821-2026
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, S…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of 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, S… by Baxter Healthcare, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0821-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-06 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
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.
Reason
CGMP Deviations
Identifiers
| ndc | 0338-0712-24 |
|---|---|
| ndc | 0338-0714-24 |
| ndc | 0338-0716-12 |
| ndc | 0338-0718-12 |
| code_info | Lot # NC193856, Exp Date: 04/18/2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0821-2026%22
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