Buprenorphine Sublingual Tablets (C-III) recall
FDA recall D-0840-2026 · initiated Aug 19, 2026
American Health Packaging recalled Buprenorphine Sublingual Tablets (C-III) in Aug 2026 — an FDA Class III recall (D-0840-2026) because Labeling: Label Mix-up.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Label Mix-up
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10,953 cartons.
Details
- 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).
- Recalling company
- American Health Packaging
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Aug 19, 2026
- FDA report date
- Sep 9, 2026
Frequently asked
- Was Buprenorphine Sublingual Tablets (C-III) recalled?
- American Health Packaging recalled Buprenorphine Sublingual Tablets (C-III) in Aug 2026 — an FDA Class III recall (D-0840-2026) because Labeling: Label Mix-up. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Buprenorphine Sublingual Tablets (C-III) recalled?
- Per the FDA enforcement record, the reason for recall D-0840-2026 was: Labeling: Label Mix-up
- Is a recalled Buprenorphine Sublingual Tablets (C-III) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Buprenorphine Sublingual Tablets (C-III) are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # 1030023, Exp Date: 06/30/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0840-2026.