# FDA recall D-0080-2024

> **Edenbridge Pharmaceuticals, LLC** · Class III · drug recall initiated 2023-10-20.

## Product

Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01

## Reason for recall

Subpotent Drug

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0080-2024
- **Recalling firm:** Edenbridge Pharmaceuticals, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-10-20
- **Report date:** 2023-11-08
- **Termination date:** 2024-08-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0080-2024

## Citation

> AI Analytics. FDA recall D-0080-2024. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0080-2024. Source: US FDA. Licensed CC0.

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