Class II · Moderate risk
Naltrexone Hydrochloride Tablets
cGMP deviations: Temperature abuse
Is Naltrexone recalled?
Not under an active recall.
Naltrexone was recalled 17 times in the past — all now closed. Most recent: Apr 13, 2022.
Most common reason: Sterility / contamination (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Naltrexone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Naltrexone recalls on record
none so far in 2026; 17 on record, newest first
Class II · Moderate risk
Naltrexone 4.5 mg/mL Suspension 30 mL bottle
Lack of Processing Control
Class II · Moderate risk
Naltrexone
Lack of Processing Control
Class II · Moderate risk
Naltrexone 4.5 mg capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Class III · Low risk
Contrave (naltrexone HCl and bupropion HCl)
Container packaging defect.
Class III · Low risk
Contrave (naltrexone HCl and bupropion HCl)
Defective Container: Customer complaints of punctures in the bottle.
Class II · Moderate risk
Naltrexone 200 mg pellet
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Naltrexone HCl USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
All naltrexone Products
Lack of Processing Controls
Class II · Moderate risk
CONTRAVE (naltrexone HCl and bupropion HCl)
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Class II · Moderate risk
Naltrexone 4.5 mg Caps
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
VIVITROL (naltrexone for extended-release injectable suspension)
Customer complaints for failure to deliver the dose.
Class II · Moderate risk
Naltrexone* Mdv 1mg/Ml Injectable
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
VIVITROL (naltrexone for extended-release injectable suspension)
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
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