# FDA recall D-0511-2026

> **Unichem Pharmaceuticals USA Inc.** · Class III · drug recall initiated 2026-04-13.

## Product

busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.

## Reason for recall

Subpotent drug

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0511-2026
- **Recalling firm:** Unichem Pharmaceuticals USA Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-13
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Brunswick, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0511-2026

## Citation

> AI Analytics. FDA recall D-0511-2026. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/D-0511-2026. Source: US FDA. Licensed CC0.

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