Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceu
Summary
The FDA issued a Class II for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bott by Graviti Pharmaceuticals Private Limited. Reason: Failed Tablet/Capsule Specifications.
Details
Source
Drug Recall
External ID
D-0037-2026
Action Date
2025-10-29
Status
Ongoing
Category
drug
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.
Lot/Code Info: Batch # BPB124341A, Exp date: 10/2026
Quantity Affected: 46,512/30 count bottles
Reason for Recall
Failed Tablet/Capsule Specifications
Distribution
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-15
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Graviti Pharmaceuticals Private Limited has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Graviti Pharmaceuticals Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Graviti Pharmaceuticals Private Limited have FDA actions?
Graviti Pharmaceuticals Private Limited has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0037-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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