Class IIIDrug
Buprenorphine Sublingual Tablets recall
Summary
American Health Packaging is recalling Buprenorphine Sublingual Tablets (C-III) (drug). According to the FDA report, the reason is: Labeling: Label Mix-up. The FDA rated this a Class III: the product is unlikely to cause health problems but violates fda rules (e.g. labeling). Recall status: Ongoing.
Details from the FDA report
- 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).
- Reason
- Labeling: Label Mix-up
- Lot / code info
- Lot # 1030023, Exp Date: 06/30/2027.
- Quantity
- 10,953 cartons.
- Distribution
- US Nationwide.
- Recalling company
- American Health Packaging, Columbus, OH United States
- Recall started
- August 19, 2026
- FDA report date
- September 9, 2026
- Classification
- Class III: The product is unlikely to cause health problems but violates FDA rules (e.g. labeling).
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0840-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (American Health Packaging) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.