FDA-Drug2026-09-09Class IIIMISBRANDING

American Health Packaging buprenorphine tablets recalled for label mix-up

LABEL MIX UPNationwide distributionDrugs

What this means

American Health Packaging distributed buprenorphine sublingual tablets with incorrect labeling. The affected medication is a prescription opioid used to treat pain and opioid use disorder. A label mix-up could result in dosing errors if patients or healthcare providers rely on incorrect information.

  • Check if your buprenorphine matches Lot #1030023 with expiration date 06/30/2027 and NDC #60687-481-21.
  • Do not use affected tablets without speaking to your pharmacist or doctor first.
  • Contact your pharmacy or healthcare provider for guidance on obtaining correctly labeled medication.
  • Do not stop taking buprenorphine abruptly without medical supervision.
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The agency's original wording
Hazard

Labeling: Label Mix-up

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
10,953 cartons.
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0840-2026

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