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Class III · Lower riskActive recall

Buprenorphine

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # 1030023, Exp Date: 06/30/2027.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Label Mix-up

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmerican Health Packaging
Brand nameBUPRENORPHINE
Generic nameBUPRENORPHINE
Active ingredient(s)BUPRENORPHINE HYDROCHLORIDE
Distributed by / forAmerican Health Packaging, Columbus, Ohio 43217, Carton
NDC60687-481-21
Show the full FDA record
Full product labelBuprenorphine 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 firmAmerican Health Packaging
DistributionUS Nationwide.
Quantity10,953 cartons.
Recall initiated2026-08-19
Report date2026-09-09
Recall completed
Recall numberD-0840-2026
ClassificationClass III
FDA statusOngoing
Origin on fileColumbus OH United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.