September 2025 FDA Recall Bupropion Hydrochloride by Graviti Pharmaceuticals Private Limited
D-0037-2026 - Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by Graviti Pharmaceuticals Private Limited on September 15, 2025 for the product Bupropion Hydrochloride. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0037-2026
Failed Tablet/Capsule Specifications
09-15-2025
10-29-2025
46,512/30 count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Graviti Pharmaceuticals Private Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
