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 16571-86

FDA recall notice · announced January 17, 2024 · Rising Pharma Holding

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Presence of Foreign Tablets/Capsules

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: BPA123098A, Exp. Date 06/2025
Quantity: 47,976 bottles
Status: Ongoing
Products in this recall event:
- 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 Pharmaceut (D-0222-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.