# FDA recall D-0097-2021

> **Ascent Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-10-26.

## Product

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01

## Reason for recall

Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0097-2021
- **Recalling firm:** Ascent Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-26
- **Report date:** 2020-11-25
- **Termination date:** 2023-02-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Central Islip, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2021

## Citation

> AI Analytics. FDA recall D-0097-2021. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0097-2021. Source: US FDA. Licensed CC0.

---

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