Buprenorphine Tablet
FDA Recall NDC 60687-492
Latest: Class III · Status: Ongoing · Initiated Aug 19, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Buprenorphine (NDC 60687-492). A significant event, classified as Class III, was initiated on Aug 19, 2026 by American Health Packaging. The reported reason for this action was: "Labeling: Label Mix-up"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Labeling: Label Mix-up
Aug 19, 2026
Sep 09, 2026
10,953 cartons.
Recall Profile & Regulatory Data
Event ID
99674
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).
Batch or Lot Expiration Information
Lot# 1030023, Exp Date: 06/30/2027.
Affected Packages Involved in this Recall
60687-481-11Buprenorphine
60687-481-21Buprenorphine
60687-492-11Buprenorphine
60687-492-21Buprenorphine
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
