CLASS III Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report
Sapropterin Dihydrochloride Powder for Oral Solution recalled
Dr. Reddy's Laboratories is recalling Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per, distributed nationwide in the US. The recall was initiated on 17 Feb 2022 and the FDA has classified it as Class III.
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-0640-2022
- FDA event ID
- 89626
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Feb 2022
- FDA classified
- 28 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 17 Feb 2022 | Recall initiated by company | |
| 28 Feb 2022 | Classified by FDA | +11 days |
| 2 Mar 2022 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
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, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per recalled?
Yes. Dr. Reddy's Laboratories recalled Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per on 17 Feb 2022. The recall is Class III and its status is Terminated. Recall number D-0640-2022.
Why was it recalled?
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Which lots are affected?
T2100891, Exp. 02/28/2024
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 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 di recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS I | Javygtor (sapropterin dihydrochloride) Powder recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS I | Sapropterin Dihydrochloride Powder for Oral Solution 100mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |