Sun Pharmaceutical Buropion 150mg Tablets Recall: Failed Dissolution Risk
Sun Pharmaceutical recalls 150mg bupropion hydrochloride extended-release tablets with failed dissolution specifications. These tablets may not release medication properly over time, risking ineffective treatment.
Lower-risk recall
Failed Dissolution Specifications; 18 month stability time point
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling specific batches of 150mg bupropion hydrochloride extended-release tablets due to failed dissolution testing. This means the medication might not release properly over time, potentially leading to ineffective treatment. Affected products were distributed through pharmacies and require immediate attention. Read more at govinfonow.com/recall/42114-sun-pharmaceutical-buropion-150mg-tablets-recall-failed-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42114-sun-pharmaceutical-buropion-150mg-tablets-recall-failed-dissolution-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0445-2017
Cite this page
“Sun Pharmaceutical Buropion 150mg Tablets Recall: Failed Dissolution Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42114-sun-pharmaceutical-buropion-150mg-tablets-recall-failed-dissolution-risk. Based on FDA recall #D-0445-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0445-2017%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they may not release medication properly over time. This could result in ineffective treatment for conditions like depression or anxiety. However, the recall focuses on stability testing at 18 months, not immediate safety risks.
Who’s affected
People prescribed bupropion hydrochloride for depression or anxiety who own the recalled tablets. Those with specific batch numbers and expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check for the product name 'buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg' with specific batch numbers and expiration dates listed in the recall. The products were distributed by Sun Pharmaceutical Industries, Inc. and have NDC codes 47335-737-86, 47335-737-88, or 47335-737-13.
- Brand
Sun Pharmaceutical- Category
Drug
All 2 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
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0445-2017 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) 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; a) 60 count JKP1184A , exp 2/17; JKP1576A, JKP2517A, JKP2527A, exp 04/17; JKP2768A exp 06/17; KP3895A, JKP4051A, exp 08/17; JKP4052A, JKP4605A exp 09/17 b) 100 count JKP0702A exp 01/17; JKP1186A exp 02/17; JKP2766A, exp 05/17; JKP3368A, JKP3369A exp 06/17; JKP3419A, JKP3420A exp 07/17; JKP4056A, JKP4603A, exp 09/17 c) 500 count JKP0093A, JKP0094A, JKP0703A, JKP0704A, exp 01/17; JKP1182A, JKP1183A, JKP1185A, exp 02/17; JKP1187A, JKP1188A, JKP1577A, JKP1578A, JKP2528A, exp 04/17; JKP2764A, JKP2765A, JKP2767A, exp 05/17; JKP3370A, JKP3371A, exp 06/17; JKP3372A, JKP3417A, JKP3418A, JKP3421A, JKP3889A, exp 07/17; JKP3892A, JKP3893A, JKP3894A, exp 08/17; JKP4053A, JKP4054A, JKP4055A, JKP4057A, JKP4600A, JKP4601A, JKP4602A, exp 09/17; JKP4742A, JKP4743A, exp 10/17 | a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles | 47335-736-86, 47335-736-88, 47335-736-08, 47335-736-13, 47335-737-86, 47335-737-88, 47335-737-08, 47335-737-13, 47335-738-86, 47335-738-88, 47335-738-08, 47335-738-13 |
| D-0446-2017 | 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; JKP0905A 04/17 | 11,618 bottles | — |
What to do — step by step
Check Product Details
Look for the product name and specific batch numbers and expiration dates listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0445-2017 (December 20, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0445-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.