Bupropion Hydrochloride Extended-Release Tablets USP (XL) recall
FDA recall D-0037-2026 · initiated Sep 15, 2025
Graviti Pharmaceuticals Private Limited recalled Bupropion Hydrochloride Extended-Release Tablets USP (XL) in Sep 2025 — an FDA Class II recall (D-0037-2026) because Failed Tablet/Capsule Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Tablet/Capsule Specifications
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
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: 46,512/30 count bottles
Details
- Product
- Bupropion 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 company
- Graviti Pharmaceuticals Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- Initiated
- Sep 15, 2025
- FDA report date
- Oct 29, 2025
Frequently asked
- Was Bupropion Hydrochloride Extended-Release Tablets USP (XL) recalled?
- Graviti Pharmaceuticals Private Limited recalled Bupropion Hydrochloride Extended-Release Tablets USP (XL) in Sep 2025 — an FDA Class II recall (D-0037-2026) because Failed Tablet/Capsule Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Bupropion Hydrochloride Extended-Release Tablets USP (XL) recalled?
- Per the FDA enforcement record, the reason for recall D-0037-2026 was: Failed Tablet/Capsule Specifications
- Is a recalled Bupropion Hydrochloride Extended-Release Tablets USP (XL) 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 Bupropion Hydrochloride Extended-Release Tablets USP (XL) are affected?
- Distributed: Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.. The recall covers these lots — Batch # BPB124341A, Exp date: 10/2026. 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-0037-2026.