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Class II · ModerateActive recall

Bupropion Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch # BPB124341A, Exp date: 10/2026
Where it was soldProduct was distributed to 1 distributor and 16 wholesalers/pharmacy retailers 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

Failed Tablet/Capsule Specifications

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 byRising Pharma Holdings, Inc.
Brand nameBUPROPION HYDROCHLORIDE
Generic nameBUPROPION HYDROCHLORIDE
Active ingredient(s)BUPROPION HYDROCHLORIDE
Distributed by / forGraviti Pharmaceuticals Private Limited
NDC16571-863-03
Show the full FDA record
Full product labelBupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
Recalling firmGraviti Pharmaceuticals Private Limited
DistributionProduct was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Quantity46,512/30 count bottles
Recall initiated2025-09-15
Report date2025-10-29
Recall completed—
Recall numberD-0037-2026
ClassificationClass II
FDA statusOngoing
Origin on fileHyderabad India

Related

Bupropion recallsRecent drug recallsCheck another medication

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.