CLASS II ONGOING Drug recall · Reported 17 Jan 2024 · FDA Enforcement Report
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg recalled
Rising Pharma Holding is recalling buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, distributed nationwide in the US. The recall was initiated on 29 Dec 2023 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-0222-2024
- FDA event ID
- 93706
- Recalling firm
- Rising Pharma Holding, East Brunswick, NJ
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Dec 2023
- FDA classified
- 11 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 29 Dec 2023 | Recall initiated by company | |
| 11 Jan 2024 | Classified by FDA | +13 days |
| 17 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules
Product as listed by the FDA
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
Where it was distributed
Nationwide within the United States
Questions about this recall
Is buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg recalled?
Yes. Rising Pharma Holding recalled buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg on 29 Dec 2023. The recall is Class II and its status is Ongoing. Recall number D-0222-2024.
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
Lot #: BPA123098A, Exp. Date 06/2025
Where was it sold?
Nationwide within the United States
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 21 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 Rising Pharma Holding
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rising, Cyproheptadine Hydrochloride Syrup, 2mg recalledCyproheptadine Hydrochloride | Rising Pharma Holding | Particulate Matter | Nationwide |
| Drug | CLASS II | Product label: Temozolomide Capsules, 5mg recalledTemozolomide | Rising Pharma Holding | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg recalledCarbidopa, Levodopa And Entacapone | Rising Pharma Holding | Packaging Defects | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 30 mg recalled | Rising Pharma Holding | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules USP 20 mg recalled | Rising Pharma Holding | Nitrosamine Impurity | Nationwide |
Other Bupropion recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg recalledBupropion Hydrochloride | Graviti Pharmaceuticals Private | Other | Nationwide |
| Drug | CLASS II | buPROPion Hydrochloride Extended-release Tablets recalledBupropion Hydrochloride | Amerisource Health Services | Potency & Assay | 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 |