# FDA recall D-0977-2018

> **Sun Pharmaceutical Industries, Inc.** · Class II · drug recall initiated 2018-07-12.

## Product

Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40

## Reason for recall

Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0977-2018
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-12
- **Report date:** 2018-08-01
- **Termination date:** 2019-03-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0977-2018

## Citation

> AI Analytics. FDA recall D-0977-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0977-2018. Source: US FDA. Licensed CC0.

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