Class II · Moderate risk
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Is Buprenorphine recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Buprenorphine (31 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Buprenorphine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Buprenorphine recalls on record
none so far in 2026; 31 on record, newest first
Class II · Moderate risk
Buprenorphine 0.1/0.05 Mg/Ml Cream
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Buprenorphine HCL Sl
Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_4, EXP: 5/13/2014; MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD54510_1, EXP: 2/28/2014.
Class II · Moderate risk
Buprenorphine 0.3 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Buprenorphine Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Buprenorphine HCl Veterinary Injection
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.