Class III · Low risk
Javygtor (sapropterin dihydrochloride)
Failed Impurities/Degradation Specifications
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Sub-potent Drug; powder discoloration associated with decreased potency
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDC
43598-0477-30
Compare with the code on your package — it is the most precise check available.
Drug: Sapropterin
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- NDC code
- 43598-477-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0486-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Sapropterin recalls
See all
Class I · High risk
Javygtor (sapropterin dihydrochloride)
Sub-potent Drug; powder discoloration associated with decreased potency
Class III · Low risk
Sapropterin Dihydrochloride Powder for Oral Solution
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Other recalls by Dr. Reddy's Laboratories, Inc.
All 2024 recalls
Class III · Low risk
Varenicline Tablets
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class I · High risk
Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
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