CLASS II ONGOING Drug recall · Reported 29 Oct 2025 · FDA Enforcement Report
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg recalled
Graviti Pharmaceuticals Private is recalling Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, distributed nationwide in the US. The recall was initiated on 15 Sep 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0037-2026
- FDA event ID
- 97629
- Recalling firm
- Graviti Pharmaceuticals Private, Hyderabad
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Sep 2025
- FDA classified
- 21 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 15 Sep 2025 | Recall initiated by company | |
| 21 Oct 2025 | Classified by FDA | +36 days |
| 29 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications
Product as listed by the FDA
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.
Where it was distributed
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications
Which lots are affected?
Batch # BPB124341A, Exp date: 10/2026
Where was it sold?
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Graviti Pharmaceuticals Private
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Furosemide Tablets, USP 40 mg recalled by Graviti PharmaceuticalsFurosemide | Graviti Pharmaceuticals Private | Other | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets, USP, 10 mg* recalled | Graviti Pharmaceuticals Private | Other | Nationwide |
Other Bupropion recalls
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | buPROPion Hydrochloride Extended-release Tablets recalledBupropion Hydrochloride | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg recalledBupropion Hydrochloride | Rising Pharma Holding | Other | Nationwide |
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg recalledBupropion Hydrochloride | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg recalledBupropion Hydrochloride | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg recalledBupropion Hydrochloride | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |