# FDA recall D-0361-2022

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2021-10-22.

## Product

Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.

## Reason for recall

Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0361-2022
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-22
- **Report date:** 2022-01-12
- **Termination date:** 2023-04-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0361-2022

## Citation

> AI Analytics. FDA recall D-0361-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0361-2022. Source: US FDA. Licensed CC0.

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