Prescription Drug Javygtor Recalled for Sub-Potency and Powder Discoloration
Dr. Reddy's Laboratories is recalling Javygtor powder packets nationwide due to powder discoloration and sub-potency. The recall affects 17,332 cartons with multiple lot numbers.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. Although no illnesses or deaths have been reported in the source, the decreased potency of a prescription medication warrants the agency's Class I designation.
Plain-English summary
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg is being recalled by Dr. Reddy's Laboratories, Inc. The recall affects 17,332 cartons distributed nationwide in the USA. The affected lot numbers are T2202812 (expiring 07/31/2025), T2204053 (expiring 10/31/2025), T2300975 and T2300976 (expiring 02/28/2026), and T2304356 (expiring 08/31/2026). The product is manufactured in India.
The FDA has classified this as a Class I recall. The product is being recalled because of powder discoloration associated with decreased potency. Affected batches contain less of the active ingredient than intended.
The recalled product
- Product
- JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
- Brand
- JAVYGTOR
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 17,332
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 (9)
- Lot #: T2202812
- Exp. 07/31/2025
- T2204053
- Exp. 10/31/2025
- T2300975
- T2300976
- Exp. 02/28/2026
- T2304356
- Exp. 08/31/2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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