# FDA recall D-1214-2018

> **LUPIN SOMERSET** · Class III · drug recall initiated 2018-08-23.

## Product

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01

## Reason for recall

Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1214-2018
- **Recalling firm:** LUPIN SOMERSET
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-23
- **Report date:** 2018-09-26
- **Termination date:** 2022-10-14

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1214-2018

## Citation

> AI Analytics. FDA recall D-1214-2018. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-1214-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*