# FDA recall D-0036-2025

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2024-10-22.

## Product

Morphine Sulfate Extended-Release Tablets 15 mg,  100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.

## Reason for recall

Failed Impurities/Degradation Specification

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0036-2025
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-10-22
- **Report date:** 2024-11-13

- **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-0036-2025

## Citation

> AI Analytics. FDA recall D-0036-2025. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-0036-2025. Source: US FDA. Licensed CC0.

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