Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88)
Failed Dissolution Specifications; 18 month stability time point
Recall notice
Failed Dissolution Specifications; 18 month stability time point
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Source Page by GovInfoNow · govinfonow.com/recall/42114-sun-pharmaceutical-industries-inc-recalls-bupropion-hydrochloride-extended-release-tablets · Recall date December 20, 2016 · FDA enforcement record: FDA #D-0445-2017
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“Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88).” GovInfoNow, recall dated December 20, 2016. https://govinfonow.com/recall/42114-sun-pharmaceutical-industries-inc-recalls-bupropion-hydrochloride-extended-release-tablets. Based on FDA recall #D-0445-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0445-2017%22&limit=1).
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- Brand
SUN PHARMACEUTICAL INDUSTRIES INC- 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 | — |
Contact SUN PHARMACEUTICAL INDUSTRIES INC
We’ve drafted a message you can send SUN PHARMACEUTICAL INDUSTRIES INC to request your refund or repair — edit it as you like.
Subject: Recall D-0445-2017 — SUN PHARMACEUTICAL INDUSTRIES INC Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochlori Hello, I own a Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) that is covered by recall D-0445-2017 from SUN PHARMACEUTICAL INDUSTRIES INC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
- 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.