# FDA recall D-0631-2018

> **Sandoz Incorporated** · Class III · drug recall initiated 2018-04-06.

## Product

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.

## Reason for recall

Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0631-2018
- **Recalling firm:** Sandoz Incorporated
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-06
- **Report date:** 2018-04-25
- **Termination date:** 2019-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Broomfield, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2018

## Citation

> AI Analytics. FDA recall D-0631-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0631-2018. Source: US FDA. Licensed CC0.

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