Bupropion Hydrochloride Tablet, Film Coated, Extended Release
FDA Recall NDC 47335-736
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 9 recorded enforcement report(s) associated with Bupropion Hydrochloride (NDC 47335-736). A significant event, classified as Class III, was initiated on Nov 22, 2023 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Dissolution Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Dissolution Specifications
Nov 22, 2023
Dec 13, 2023
2016 Bottles
Recall Profile & Regulatory Data
Event ID
93472
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 27, 2024
Product Description
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
Batch or Lot Expiration Information
Lot# Lot HAD0630A, exp 1/2024
Affected Packages Involved in this Recall
47335-736-86Product
47335-736-88Product
47335-736-08Product
47335-736-13Product
47335-737-86Product
47335-737-88Product
47335-737-08Product
47335-737-13Product
47335-738-86Product
47335-738-88Product
47335-738-08Product
47335-738-13Product
Class III Terminated
Failed Dissolution Specifications
Oct 04, 2023
Oct 25, 2023
144 bottles
Recall Profile & Regulatory Data
Event ID
93166
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Feb 02, 2024
Product Description
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86
Batch or Lot Expiration Information
Lot# : HAD0360A, Exp. 12/2023
Affected Packages Involved in this Recall
47335-736-86Product
47335-736-88Product
47335-736-08Product
47335-736-13Product
47335-737-86Product
47335-737-88Product
47335-737-08Product
47335-737-13Product
47335-738-86Product
47335-738-88Product
47335-738-08Product
47335-738-13Product
May 2023 Class II Recall: Failed Dissolution Specifications; during stability testing
Recall Number
Class II Terminated
Failed Dissolution Specifications; during stability testing
May 09, 2023
May 31, 2023
5,344 Bottles
Recall Profile & Regulatory Data
Event ID
92289
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A
Termination Date
Feb 27, 2024
Product Description
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Batch or Lot Expiration Information
Lot# Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
Affected Packages Involved in this Recall
47335-736-86Product
47335-736-88Product
47335-736-08Product
47335-736-13Product
47335-737-86Product
47335-737-88Product
47335-737-08Product
47335-737-13Product
47335-738-86Product
47335-738-88Product
47335-738-08Product
47335-738-13Product
Class III Terminated
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Apr 29, 2022
May 18, 2022
744 bottles
Recall Profile & Regulatory Data
Event ID
90088
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 25, 2023
Product Description
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86
Batch or Lot Expiration Information
Lot# : HAC2237A, exp. date 05/2023
Affected Packages Involved in this Recall
47335-736-86Product
47335-736-88Product
47335-736-08Product
47335-736-13Product
47335-737-86Product
47335-737-88Product
47335-737-08Product
47335-737-13Product
47335-738-86Product
47335-738-88Product
47335-738-08Product
47335-738-13Product
Class III Terminated
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Apr 29, 2022
May 18, 2022
9804 bottles
Recall Profile & Regulatory Data
Event ID
90088
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 25, 2023
Product Description
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India
Batch or Lot Expiration Information
Lot# : a) JKX5126A, JKX5127A, JKX5128A, Exp 10/2022; b) JKX5126B , JKX5128B, Exp 10/2022; c)JKX5126C, JKX5127C, JKX5128C, Exp 10/2022
Affected Packages Involved in this Recall
47335-736-86Product
47335-736-88Product
47335-736-08Product
47335-736-13Product
47335-737-86Product
47335-737-88Product
47335-737-08Product
47335-737-13Product
47335-738-86Product
47335-738-88Product
47335-738-08Product
47335-738-13Product
December 2016 Class III Recall: Failed Dissolution Specifications; 18 month stability time point
Recall Number
Class III Terminated
Failed Dissolution Specifications; 18 month stability time point
Dec 20, 2016
Feb 01, 2017
a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles
Recall Profile & Regulatory Data
Event ID
76282
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 11, 2018
Product Description
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
47335-736-86Product
47335-736-88Product
47335-736-08Product
47335-736-13Product
47335-737-86Product
47335-737-88Product
47335-737-08Product
47335-737-13Product
47335-738-86Product
47335-738-88Product
47335-738-08Product
47335-738-13Product
Class III Terminated
Failed Dissolution Specifications
Sep 13, 2016
Oct 12, 2016
31,762 bottles
Recall Profile & Regulatory Data
Event ID
75206
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 02, 2018
Product Description
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86
Batch or Lot Expiration Information
Lot# JKN5124A and JKN5229A, exp 10/2016
Affected Packages Involved in this Recall
47335-736-86Product
47335-736-88Product
47335-736-08Product
47335-736-13Product
47335-737-86Product
47335-737-88Product
47335-737-08Product
47335-737-13Product
47335-738-86Product
47335-738-88Product
47335-738-08Product
47335-738-13Product
3473357378Product
Class III Terminated
Failed Dissolution Specifications
Jun 27, 2016
Jul 27, 2016
16,085 bottles
Recall Profile & Regulatory Data
Event ID
74696
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 27, 2018
Product Description
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
Batch or Lot Expiration Information
Lot# Lot JKN3477A, exp 07/2016
Affected Packages Involved in this Recall
47335-736-86Product
47335-736-88Product
47335-736-08Product
47335-736-13Product
47335-737-86Product
47335-737-88Product
47335-737-08Product
47335-737-13Product
47335-738-86Product
47335-738-88Product
47335-738-08Product
47335-738-13Product
Class III Terminated
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Jul 17, 2015
Aug 26, 2015
35,235 bottles
Recall Profile & Regulatory Data
Event ID
71949
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sun Pharma Global Fze
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Mar 22, 2016
Product Description
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
Batch or Lot Expiration Information
Lot# s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
Affected Packages Involved in this Recall
47335-736-86Product
47335-736-88Product
47335-736-08Product
47335-736-13Product
47335-737-86Product
47335-737-88Product
47335-737-08Product
47335-737-13Product
47335-738-86Product
47335-738-88Product
47335-738-08Product
47335-738-13Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
