# FDA recall D-0669-2025

> **Granules Pharmaceuticals Inc.** · Class III · drug recall initiated 2025-08-28.

## Product

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01

## Reason for recall

Failed Impurities/Degradation Specifications:

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0669-2025
- **Recalling firm:** Granules Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-28
- **Report date:** 2025-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chantilly, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0669-2025

## Citation

> AI Analytics. FDA recall D-0669-2025. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0669-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*