Class II · Moderate risk
Nexterone (amiodarone HCI)
CGMP Deviations
Is Amiodarone recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Amiodarone (9 total). Check the affected lots below.
Most common reason: Failed specification (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amiodarone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Amiodarone recalls in 2026
1 initiated in 2026, 9 in total — newest first
Class I · High risk
Amiodarone Hydrochloride Injection
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class I · High risk
Nexterone (amiodarone HCl)
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Class II · Moderate risk
Amiodarone 900 mg in dextrose 5% 500 mL
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk
Amiodarone all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Amiodarone HCl Injection
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
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