# FDA recall D-0825-2020

> **Spectrum Laboratory Products** · Class II · drug recall initiated 2020-01-14.

## Product

Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

## Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

## Distribution

The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.

## Key facts

- **Recall number:** D-0825-2020
- **Recalling firm:** Spectrum Laboratory Products
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-14
- **Report date:** 2020-02-12
- **Termination date:** 2023-12-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gardena, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0825-2020

## Citation

> AI Analytics. FDA recall D-0825-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0825-2020. Source: US FDA. Licensed CC0.

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