Why it was recalled
CGMP Deviations
Product description
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.
Lot numbers, UPCs & expiration codes
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, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.
Where it was sold
US Nationwide; Puerto Rico; and Chile.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0814-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 6, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0814-2026, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99500
- Address
- 1 Baxter Pkwy
- Code information
- 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, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.
- Postal code
- 60015-4625
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0814-2026
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide; Puerto Rico; and Chile.
- Recall initiation date
- Aug 6, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2026