CLASS III Drug recall · Reported 1 Feb 2017 · FDA Enforcement Report
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg recalled
Sun Pharmaceutical Industries is recalling buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, distributed nationwide in the US. The recall was initiated on 20 Dec 2016 and the FDA has classified it as Class III.
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-0446-2017
- FDA event ID
- 76282
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Dec 2016
- FDA classified
- 25 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 20 Dec 2016 | Recall initiated by company | |
| 25 Jan 2017 | Classified by FDA | +36 days |
| 1 Feb 2017 | Published in enforcement report | +7 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; 18 month stability time point
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
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications; 18 month stability time point
Which lots are affected?
JKP0905A 04/17
Where was it sold?
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
1 other product · FDA event 76282This product is part of a recall event; the main page for the event is buPROPion Hydrochloride Extended-release Tablets, USP (SR) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | buPROPion Hydrochloride Extended-release Tablets, USP (SR) recalledBupropion Hydrochloride | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
More recalls from Sun Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Bupropion recalls
All 31| 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 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 |