Class II · Moderate risk
Naloxone Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Naloxone recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Naloxone (11 total). Check the affected lots below.
Most common reason: Impurity / degradation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Naloxone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Naloxone recalls on record
none so far in 2026; 11 on record, newest first
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Presence of Foreign Substance
Class II · Moderate risk
Narcan (naloxone HCl)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 4mg/1mg 30 Pouches…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Class II · Moderate risk
Naloxone HCL Preserved INJ
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class I · High risk
Naloxone Hydrochloride Injection
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Class III · Low risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk
Buprenorphine and Naloxone Sublingual Tablets
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Naloxone HCL* 0.4mg/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.
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