CLASS III Drug recall · Reported 19 Apr 2017 · FDA Enforcement Report
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg recalled
Jubilant Cadista Pharmaceuticals is recalling BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, distributed nationwide in the US. The recall was initiated on 8 Apr 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-0670-2017
- FDA event ID
- 76982
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Salisbury, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Apr 2016
- FDA classified
- 13 Apr 2017
- Reported
- 19 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 8 Apr 2016 | Recall initiated by company | |
| 13 Apr 2017 | Classified by FDA | +370 days |
| 19 Apr 2017 | 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
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
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), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Which lots are affected?
Lot #s: a) BU25001A, Exp 12/16; BU25002A, BU25003A, BU25004A, Exp 01/17; b) BU24003A, Exp 10/16; BU24004A, BU24005A, Exp 11/16; BU25005A, Exp 01/17
Where was it sold?
Nationwide in the USA
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
2 other products · FDA event 76982| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg recalled | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS III | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg recalled | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Jubilant Cadista Pharmaceuticals
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride | Jubilant Cadista Pharmaceuticals | Labeling Errors | 5 states |
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 |