# FDA recall D-0037-2026

> **Graviti Pharmaceuticals Private Limited** · Class II · drug recall initiated 2025-09-15.

## 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.

## Reason for recall

Failed Tablet/Capsule Specifications

## Distribution

Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.

## Key facts

- **Recall number:** D-0037-2026
- **Recalling firm:** Graviti Pharmaceuticals Private Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-15
- **Report date:** 2025-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hyderabad, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0037-2026

## Citation

> AI Analytics. FDA recall D-0037-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0037-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*