# FDA recall D-0069-2021

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2020-10-28.

## Product

Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.

## Reason for recall

Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

## Distribution

Nationwide in the U.S. and PR

## Key facts

- **Recall number:** D-0069-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-28
- **Report date:** 2020-11-18
- **Termination date:** 2021-08-26

- **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-0069-2021

## Citation

> AI Analytics. FDA recall D-0069-2021. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/D-0069-2021. Source: US FDA. Licensed CC0.

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