# FDA recall D-0055-2018

> **AVKARE Inc.** · Class II · drug recall initiated 2017-10-06.

## Product

Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.

## Reason for recall

Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0055-2018
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-06
- **Report date:** 2017-11-08
- **Termination date:** 2019-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0055-2018

## Citation

> AI Analytics. FDA recall D-0055-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0055-2018. Source: US FDA. Licensed CC0.

---

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