Medications & Supplements/Prescription Drugs

Dr. Reddy's Sapropterin Dihydrochloride Powder Recalled for Subpotency

Agency Publication Date: February 23, 2022

Summary

Sapropterin Dihydrochloride Powder for Oral Solution (100 mg), distributed by Dr. Reddy's Laboratories, Inc., is being recalled because tests showed the medication was subpotent, meaning it may not contain the correct amount of active ingredient. The recall involves approximately 340 packets of the medication. No incidents or injuries related to this subpotency have been reported.

Risk

Because the medication is subpotent, it may not work as effectively as intended to manage the patient's condition. This could lead to a lack of therapeutic effect for consumers using the affected lot.

What You Should Do

This recall affects Dr. Reddy's Sapropterin Dihydrochloride Powder for Oral Solution (100 mg) sold in 30-count cartons (NDC 43598-477-30) or individual packets (NDC 43598-477-11) labeled with lot number T2100891 and an expiration date of 02/28/2024.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sapropterin Dihydrochloride Powder for Oral Solution

Variants: 100 mg, 30 individual packets per carton, Rx Only

Lot Numbers:

T2100891 (Exp. 02/28/2024)

NDC:

43598-477-11

43598-477-30

Recall #: D-0640-2022; Quantity: 340 packets

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89626

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: pharmacies

Manufactured In: India

Units Affected: 340 packets

Distributed To: Nationwide

Agency Last Updated: February 28, 2022

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Dr. Reddy's Sapropterin Dihydrochloride Powder for Oral Solution (100 mg) sold in 30-count cartons (NDC 43598-477-30) or individual packets (NDC 43598-477-11) labeled with lot number T2100891 and an expiration date of 02/28/2024.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.