CLASS I ONGOING Drug recall · Reported 15 May 2024 · FDA Enforcement Report
Sapropterin Dihydrochloride Powder for Oral Solution 100mg recalled
Dr. Reddy's Laboratories is recalling Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per, distributed nationwide in the US. The recall was initiated on 8 Apr 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0486-2024
- FDA event ID
- 94369
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Apr 2024
- FDA classified
- 6 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 8 Apr 2024 | Recall initiated by company | |
| 6 May 2024 | Classified by FDA | +28 days |
| 15 May 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-potent Drug; powder discoloration associated with decreased potency
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Sub-potent Drug; powder discoloration associated with decreased potency
Which lots are affected?
Lot # T2200352, Exp. 12/31/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94369| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Javygtor (sapropterin dihydrochloride) Powder recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Sapropterin Dihydrochloride For recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Sapropterin Dihydrochloride Powder for Oral Solution recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |