Jubilant BuPROPion Recall: Impurity Issue
Jubilant Cadista recalls 150 mg BuPROPion tablets due to high levels of a degradation product. Check lot numbers and expiration dates.
Recall notice
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Contact the company
What happened, in plain English
Jubilant Cadista Pharmaceuticals is recalling specific lots of BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg because they contain out-of-specification levels of a known degradation product called m-chlorobenzoic acid. The recall affects both 60-count and 100-count bottles distributed nationwide in the USA. The record does not specify what consumers should do with these medications or if there is an immediate health risk. Read more at govinfonow.com/recall/43007-jubilant-bupropion-recall-impurity-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/43007-jubilant-bupropion-recall-impurity-issue · Updated October 11, 2026 · FDA enforcement record: FDA #D-0670-2017
Cite this page
“Jubilant BuPROPion Recall: Impurity Issue.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43007-jubilant-bupropion-recall-impurity-issue. Based on FDA recall #D-0670-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0670-2017%22&limit=1).
Why it’s dangerous
The recalled tablets failed impurity specifications because they contained high levels of m-chlorobenzoic acid, which is a known degradation product. The record does not explain the specific health effects or severity of this impurity level.
Who’s affected
Patients in the USA who have been prescribed or purchased BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg from the specific lots listed in the record. The manufacturer is Jubilant Cadista Pharmaceuticals, Inc., and the product was manufactured by Julibant Life Sciences Ltd. in India.
How to tell if you have this one
Check your medication bottle for the National Drug Code (NDC) numbers 59746-316-60 (60-count bottles) or 59746-316-01 (100-count bottles). Verify the lot number and expiration date against the following list: Lot BU25001A (Exp 12/16); Lots BU25002A, BU25003A, BU25004A (Exp 01/17); Lot BU24003A (Exp 10/16); Lots BU24004A, BU24005A (Exp 11/16); and Lot BU25005A (Exp 01/17).
- Brand
Jubilant Cadista- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0669-2017 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.; Lot #s: a) BU15001B, BU15003D, Exp 12/16; b) BU15002A, Exp 12/16 | 20,882 bottles |
| D-0670-2017 | 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.; 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 | 81,077 bottles |
| D-0671-2017 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.; Lot #s: a) BU34002A, BU34003A, Exp 11/16; b) BU34001A, Exp 10/16 | 19,682 bottles |
What to do — step by step
Check your medication details
Compare the NDC, lot number, and expiration date on your bottle against the recalled lots listed in the record.
Contact your pharmacist or doctor
The recall record does not state a specific remedy, so you should consult your healthcare provider for guidance on what to do next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- FDA terminated the recall
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0670-2017 (April 8, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0670-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.