Lower risk Drug recall · FDA · Published April 8, 2024

Dr. Reddy's Sapropterin Dihydrochloride Powder Recall: Sub-potent Drug Risk

Dr. Reddy's recalls 100mg Sapropterin Dihydrochloride Powder for Oral Solution due to potential decreased potency from discoloration. Affected units have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0486-2024Drug Dr. Reddy's ›

Lower-risk recall

Sub-potent Drug; powder discoloration associated with decreased potency

Take action

Contact the company

Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623

✎ GovInfoNow plain-language explainer

Dr. Reddy's is recalling Sapropterin Dihydrochloride Powder for Oral Solution 100mg because the powder may discolor and lose potency. This could affect the drug's effectiveness for patients using it under a prescription. Read more at govinfonow.com/recall/32747-dr-reddy-s-sapropterin-dihydrochloride-powder-recall-sub-potent-drug.

Source Summary by GovInfoNow · govinfonow.com/recall/32747-dr-reddy-s-sapropterin-dihydrochloride-powder-recall-sub-potent-drug · Updated August 17, 2026 · FDA enforcement record: FDA #D-0486-2024

Cite this page

“Dr. Reddy's Sapropterin Dihydrochloride Powder Recall: Sub-potent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32747-dr-reddy-s-sapropterin-dihydrochloride-powder-recall-sub-potent-drug. Based on FDA recall #D-0486-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0486-2024%22&limit=1).

The FDA announced on April 8, 2024, that Dr. Reddy's Laboratories is voluntarily recalling Sapropterin Dihydrochloride Powder for Oral Solution due to sub-potent drug risks and powder discoloration. Owners should contact the company for a full refund. This Class I recall affects 2,402 cartons distributed nationwide.

How to tell if you have it

Brand: Dr. Reddy's
Product: Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Packaging: 30 individual packets per carton
NDC: 43598-477-30
Lot #: T2200352
Expiration Date: 12/31/2024
Quantity: 2,402 cartons

The hazard

The recall addresses sub-potent drug risks and powder discoloration associated with decreased potency. The FDA classified this as a Class I recall, indicating the highest risk of adverse health consequences.

Context

GovInfoNow's records show Dr. Reddy's Laboratories has 85 other recalls on record since April 9, 2012. Recent brand recalls include a Varenicline Tablets recall on November 11, 2025, for subpotent drug risk and a Succinylcholine Chloride Injection recall on September 26, 2025, for stability testing issues. Other recent recalls of similar products include CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (March 18, 2026), Hikma Ramipril Capsules 10mg Recall (August 24, 2026), and ImprimisRx Povidone Iodine Ophthalmic Solution Recall (August 24, 2026).

How to tell if you have this one

Check for the product name 'Sapropterin Dihydrochloride Powder for Oral Solution 100mg', 30 packets per carton, and lot number T2200352. The expiration date is December 31, 2024.

Brand
Dr. Reddy's
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity	NDC
D-0485-2024	Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.; Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.	17,332 cartons	43598-097-11, 43598-097-30
D-0486-2024	Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.; Lot # T2200352, Exp. 12/31/2024	2402 cartons	—

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot number and expiration date on the packaging to confirm if it matches T2200352 and December 31, 2024.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 37 days after the firm started it.

Apr 8, 2024Firm started the recall
May 6, 2024FDA classified it Class I
May 15, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury from this product?

No, the hazard is about decreased potency, not physical harm or injury.

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Link to this recall

<a href="https://govinfonow.com/recall/32747-dr-reddy-s-sapropterin-dihydrochloride-powder-recall-sub-potent-drug">Dr. Reddy's Sapropterin Dihydrochloride Powder Recall: Sub-potent Drug Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0486-2024 (April 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0486-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.