Bupropion Hydrochloride Tablet, Extended Release
FDA Recall NDC 16571-862
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Bupropion Hydrochloride (NDC 16571-862). A significant event, classified as Class II, was initiated on Sep 15, 2025 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Tablet/Capsule Specifications
Sep 15, 2025
Oct 29, 2025
46,512/30 count bottles
Recall Profile & Regulatory Data
Event ID
97629
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Graviti Pharmaceuticals Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Product Description
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
Batch or Lot Expiration Information
Batch# BPB124341A, Exp date: 10/2026
Affected Packages Involved in this Recall
16571-862-03Product
16571-862-09Product
16571-862-50Product
16571-862-10Product
16571-862-12Product
16571-863-03Product
16571-863-09Product
16571-863-50Product
16571-863-10Product
Class II Ongoing
Presence of Foreign Tablets/Capsules
Dec 29, 2023
Jan 17, 2024
47,976 bottles
Recall Profile & Regulatory Data
Event ID
93706
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Rising Pharma Holding, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
Batch or Lot Expiration Information
Lot# : BPA123098A, Exp. Date 06/2025
Affected Packages Involved in this Recall
16571-862-03Product
16571-862-09Product
16571-862-50Product
16571-862-10Product
16571-862-12Product
16571-863-03Product
16571-863-09Product
16571-863-50Product
16571-863-10Product
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.
