August 2026 FDA Recall Buprenorphine by American Health Packaging
D-0840-2026 - Labeling
This Class III drug recall was voluntarily initiated by American Health Packaging on August 19, 2026 for the product Buprenorphine. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0840-2026
Labeling: Label Mix-up
08-19-2026
09-09-2026
10,953 cartons.
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
American Health Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
