Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
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 Laboratories, Inc. is recalling Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, in 30-packet cartons. The recall was issued because laboratory testing showed the drug was subpotent and out of specification for its assay. This means the medication may not contain the expected amount of active ingredient. Read more at govinfonow.com/recall/35213-dr-reddy-s-recalls-sapropterin-powder-due-to-subpotency.
“Dr. Reddy's Recalls Sapropterin Powder Due to Subpotency.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35213-dr-reddy-s-recalls-sapropterin-powder-due-to-subpotency. Based on FDA recall #D-0640-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0640-2022%22&limit=1).
The FDA announced on Feb. 17, 2022, that Dr. Reddy's Laboratories voluntarily recalled Sapropterin Dihydrochloride Powder for Oral Solution due to subpotent drug risks. The recall affects 340 packets distributed nationwide.
How to tell if you have it
Brand: Dr. Reddy's
Product: Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg
Packaging: 30 individual packets per carton
NDC: 43598-477-11 (packet), 43598-477-30 (carton)
Lot code: T2100891, Exp. 02/28/2024
Quantity: 340 packets
The hazard
The recall was initiated because out-of-specification results were observed in the assay of the sapropterin dihydrochloride powder 100mg, resulting in a subpotent drug. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Dr. Reddy's Laboratories has 85 other recalls on record since April 9, 2012. Other recent recalls of similar products include Dr. Reddy's Varenicline Tablets Recall (Nov. 11, 2025), Dr. Reddy's Succinylcholine Chloride Injection Recall (Sept. 26, 2025), and Dr. Reddy's Omeprazole Capsules Recall (June 30, 2025). Other recent recalls of similar products include Specialty Process Labs Thyroid Product Recall (Jan. 16, 2026), CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (March 18, 2026), and Major Pharmaceuticals Levothyroxine Tablets Recall (July 13, 2026).
How to tell if you have this one
Check your medication for the NDC numbers 43598-477-11 (packet) and 43598-477-30 (carton). Look for the lot number T2100891 and an expiration date of 02/28/2024. The product is Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, in 30 individual packets per carton.
Brand
Dr. Reddy's
Category
Drug
Based on the official FDA remedy
What to do — step by step
Contact Your Healthcare Provider
Inform your doctor or pharmacist about the recall to discuss alternative treatment options or replacement medication.
Do Not Use Affected Lots
If you have the recalled product with lot number T2100891 and expiration date 02/28/2024, stop using it immediately.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
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 terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0640-2022 (February 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0640-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.