# FDA recall D-0640-2022

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2022-02-17.

## Product

Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).

## Reason for recall

Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0640-2022
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-17
- **Report date:** 2022-03-02
- **Termination date:** 2025-01-29

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0640-2022

## Citation

> AI Analytics. FDA recall D-0640-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0640-2022. Source: US FDA. Licensed CC0.

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