FDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications
Dr. Reddy's Laboratories is recalling 7,233 bottles of JAVYGTOR (sapropterin dihydrochloride) tablets nationwide because the medication failed specifications for impurities and degradation products. Affected patients should contact their healthcare provider.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard is potential presence of impurities and degradation products in a pharmaceutical, which represents a quality concern but is classified as unlikely to cause adverse health consequences.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 7,233 bottles of JAVYGTOR (sapropterin dihydrochloride) 100mg tablets distributed nationwide. The recalled product was manufactured in India and is available by prescription only.
The recall was initiated due to the medication failing specifications for impurities and degradation products. This FDA Class III recall involves multiple lot numbers with expiration dates ranging from January 2025 through August 2025.
Patients who received this medication should contact their healthcare provider to discuss whether their prescription is affected and what steps to take. Do not discontinue taking the medication without first consulting with your healthcare provider. Pharmacy staff and patients should check lot numbers to determine if they have affected product.
For more information about affected lot numbers and the recall, consumers can contact the FDA or Dr. Reddy's Laboratories directly.
The recalled product
- Product
- JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
- Brand
- JAVYGTOR
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug
- Hazard
- Affected units
- 7,233
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lot #: T2300653
- Exp 01/31/2025
- T2303956
- T2303750
- Exp 06/30/2025
- T2304190
- T2304987
- Exp 08/31/2025
- T2302026
- Exp 03/31/2025
- T2302526
- Exp 05/31/2025.
UPCs (1)
- 0343598096049
Distribution
Distributed nationwide across the United States.
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