# FDA recall D-0788-2020

> **Sun Pharmaceutical Industries, Inc.** · Class II · drug recall initiated 2020-01-14.

## Product

Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India

## Reason for recall

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

## Distribution

Product was distributed throughout the United States.

## Key facts

- **Recall number:** D-0788-2020
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-14
- **Report date:** 2020-01-22
- **Termination date:** 2020-08-31

- **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-0788-2020

## Citation

> AI Analytics. FDA recall D-0788-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0788-2020. Source: US FDA. Licensed CC0.

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