# FDA recall D-0019-2015

> **Valeant Pharmaceuticals North America LLC** · Class III · drug recall initiated 2014-05-21.

## Product

Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada    2.5 mg  90 ct -  NDC 0187-0140-90    5 mg 30 ct - NDC  0187-0141-30    5 mg 90 ct - NDC 0187-0141-90    10 mg 30 ct - NDC 0187-0142-30    10 mg 90 ct - NDC 0187-0142-90    10 mg  1000 ct - NDC 0187-0142-10      20 mg 30 ct - NDC 0187-0143-30    20 mg 90 ct - NDC 0187-0143-90     20 mg 1000 ct - NDC 0187-0143-10          NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles

## Reason for recall

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0019-2015
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-05-21
- **Report date:** 2014-10-22
- **Termination date:** 2015-08-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0019-2015

## Citation

> AI Analytics. FDA recall D-0019-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0019-2015. Source: US FDA. Licensed CC0.

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