# FDA recall D-0301-2026

> **Unichem Pharmaceuticals USA Inc.** · Class II · drug recall initiated 2026-01-21.

## Product

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01

## Reason for recall

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

## Distribution

US Nationwide and PR.

## Key facts

- **Recall number:** D-0301-2026
- **Recalling firm:** Unichem Pharmaceuticals USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-01-21
- **Report date:** 2026-02-11

- **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-0301-2026

## Citation

> AI Analytics. FDA recall D-0301-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0301-2026. Source: US FDA. Licensed CC0.

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