# FDA recall D-0862-2020

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2020-02-20.

## Product

Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count 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: Low out of specification dissolution result observed during stability testing.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0862-2020
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-02-20
- **Report date:** 2020-03-11
- **Termination date:** 2020-10-06

- **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-0862-2020

## Citation

> AI Analytics. FDA recall D-0862-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0862-2020. Source: US FDA. Licensed CC0.

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