# FDA recall D-0836-2018

> **LUPIN SOMERSET** · Class III · drug recall initiated 2018-05-24.

## Product

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873  Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020  NDC 43386-356-10  UPC 343386356102

## Reason for recall

Labeling: Missing Label

## Distribution

OH

## Key facts

- **Recall number:** D-0836-2018
- **Recalling firm:** LUPIN SOMERSET
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-24
- **Report date:** 2018-06-06
- **Termination date:** 2021-01-26

- **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-0836-2018

## Citation

> AI Analytics. FDA recall D-0836-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0836-2018. Source: US FDA. Licensed CC0.

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