Medications & Supplements/Prescription Drugs

Javygtor and Sapropterin Dihydrochloride Recalled for Sub-potency

Agency Publication Date: May 6, 2024

Summary

Dr. Reddy's Laboratories, Inc. is recalling 19,734 cartons of Javygtor (sapropterin dihydrochloride) and generic Sapropterin Dihydrochloride Powder for Oral Solution 100mg. The medicine is being recalled because the powder may be discolored, which is linked to the drug being sub-potent. When a drug is sub-potent, it means the medication is less effective than required for proper treatment.

Risk

The discolored powder indicates that the medication has degraded and is not at full strength. Using sub-potent medication may lead to ineffective treatment of the patient's underlying medical condition.

What You Should Do

This recall affects Javygtor (sapropterin dihydrochloride) and generic Sapropterin Dihydrochloride Powder for Oral Solution 100mg, sold in cartons of 30 individual packets.
Check your medication packaging for NDC codes 43598-097-30 or 43598-477-30 and lot numbers including T2202812, T2204053, T2300975, T2300976, T2304356, or T2200352. See the Affected Products section below for the full list of affected codes and expiration dates.
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 regarding this recall.

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: Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg

Variants: 100mg, Powder for Oral Solution, 30 individual packets per carton

Lot Numbers:

T2202812 (Exp. 07/31/2025)

T2204053 (Exp. 10/31/2025)

T2300975 (Exp. 02/28/2026)

T2300976 (Exp. 02/28/2026)

T2304356 (Exp. 08/31/2026)

NDC:

43598-097-30

Recall #: D-0485-2024; Distributor: Dr. Reddy's Laboratories Inc.

Product: Sapropterin Dihydrochloride Powder for Oral Solution 100mg

Variants: 100mg, Powder for Oral Solution, 30 individual packets per carton

Lot Numbers:

T2200352 (Exp. 12/31/2024)

NDC:

43598-477-30

Recall #: D-0486-2024; Distributor: Dr. Reddy's Laboratories Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94369

Status: Active

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 2 products (17,332 cartons; 2402 cartons)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 · FDA Press Release · 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 Javygtor (sapropterin dihydrochloride) and generic Sapropterin Dihydrochloride Powder for Oral Solution 100mg, sold in cartons of 30 individual packets.

Check your medication packaging for NDC codes 43598-097-30 or 43598-477-30 and lot numbers including T2202812, T2204053, T2300975, T2300976, T2304356, or T2200352. See the Affected Products section below for the full list of affected codes and expiration dates.

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 regarding this recall.

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: Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg

Variants: 100mg, Powder for Oral Solution, 30 individual packets per carton

Lot Numbers:

T2202812 (Exp. 07/31/2025)

T2204053 (Exp. 10/31/2025)

T2300975 (Exp. 02/28/2026)

T2300976 (Exp. 02/28/2026)

T2304356 (Exp. 08/31/2026)

NDC:

43598-097-30

Recall #: D-0485-2024; Distributor: Dr. Reddy's Laboratories Inc.

Product: Sapropterin Dihydrochloride Powder for Oral Solution 100mg

Variants: 100mg, Powder for Oral Solution, 30 individual packets per carton

Lot Numbers:

T2200352 (Exp. 12/31/2024)

NDC:

43598-477-30

Recall #: D-0486-2024; Distributor: Dr. Reddy's Laboratories Inc.