Nexterone , 360 mg/200 mL in GALAXY Single-Dose Container, sterile Recall 2026
NEXTERONEIssued August 6, 2026Updated Reviewed by the Recall Watch editorial team
NEXTERONE Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made — recalled per FDA on 8/6/2026. Reason: CGMP Deviations.
- Agency
- FDA
- Issued
- Aug 6, 2026
- Brand
- NEXTERONE
- Distribution
- 1 states
- Lots affected
- 20
Steps to take for this recall
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
Verify the match
Compare lot numbers, UPCs, and dates against your product.
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
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What's recalled
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
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Why it was recalled
CGMP Deviations
Affected products & lot numbers20 lots called out
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| Lot # NC177832 |
| Exp Date: 12/31/2026 |
| Lot # NC185417 |
| NC185455 |
| Exp Date: 08/31/2027 |
| Lot # NC188593 |
| Exp Date: 11/30/2027 |
| Lot # NC188647 |
| NC188685 |
| NC188807 |
| NC188838 |
| NC188920 |
| Exp Date: 12/31/2027 |
| Lot # NC193603 |
| NC193726 |
| NC193788 |
| NC193863 |
| NC193900 |
| Exp Date: 04/30/2028 |
| Lot # NC194082 |
Where was it sold1 state
US Nationwide; Puerto Rico; and Chile.
More recalls like this4 related — by brand, contaminant, and category
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Frequently asked questions
Is the NEXTERONE recall still active?
Yes, this recall is currently active as of August 6, 2026. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: Lot # NC177832, Exp Date: 12/31/2026, Lot # NC185417, NC185455, Exp Date: 08/31/2027, Lot # NC188593, Exp Date: 11/30/2027, Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027, Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028, Lot # NC194082. Check the label on your product.
What should I do if I have the recalled NEXTERONE?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.