# FDA recall D-0520-2026

> **JB Chemicals and Pharmaceuticals Ltd** · Class II · drug recall initiated 2026-04-23.

## Product

Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.

## Reason for recall

Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0520-2026
- **Recalling firm:** JB Chemicals and Pharmaceuticals Ltd
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-23
- **Report date:** 2026-05-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0520-2026

## Citation

> AI Analytics. FDA recall D-0520-2026. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0520-2026. Source: US FDA. Licensed CC0.

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