Class II · Moderate risk
Nalbuphine
Lack of sterility assurance
Is Nalbuphine recalled?
Not under an active recall.
Nalbuphine was recalled 5 times in the past — all now closed. Most recent: Dec 27, 2022.
Most common reason: Sterility / contamination (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nalbuphine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Nalbuphine recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
Nalbuphine all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Nalbuphine 10 mg/mL injection solution packaged in an amber glass injectable vial
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Nalbuphine HCL 20 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
Nalbuphine HCl Injection
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
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