CLASS II Drug recall · Reported 31 May 2023 · FDA Enforcement Report
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg recalled
SUN Pharmaceutical Industries is recalling buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, distributed nationwide in the US. The recall was initiated on 9 May 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-0761-2023
- FDA event ID
- 92289
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2023
- FDA classified
- 23 May 2023
- Reported
- 31 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 9 May 2023 | Recall initiated by company | |
| 23 May 2023 | Classified by FDA | +14 days |
| 31 May 2023 | 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 Dissolution Specifications; during stability testing
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Where it was distributed
Nationwide in the U.S.A
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications; during stability testing
Which lots are affected?
Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
Where was it sold?
Nationwide in the U.S.A
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 SUN Pharmaceutical Industries
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|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
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Other Bupropion recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg recalled | 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 | BuPROPion Hydrochloride Tablets, USP 75 mg (10 recalledBupropion Hydrochloride | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg recalledBupropion Hydrochloride | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |