Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Sapropterin Dihydrochloride Powder for Oral Solution 100mg Recalled by Dr. Reddy's Laboratories, Inc. Due to Sub-potent Drug; powder discoloration associated with decreased potency
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dr. Reddy's Laboratories, Inc. directly.
Affected Products
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.
Quantity: 2402 cartons
Why Was This Recalled?
Sub-potent Drug; powder discoloration associated with decreased potency
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Laboratories, Inc. has 163 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report