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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94369

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 08, 2024
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Dr. Reddy's Laboratories, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

Javygtor (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 43598-097-30.

D-0485-2024
Recall number
D-0485-2024
Initiated
April 08, 2024
Classification
Class I
Status
Ongoing
Quantity
17,332 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sub-potent Drug; powder discoloration associated with decreased potency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Sub-potent Drug; powder discoloration associated with decreased potency

Code information

Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

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.

D-0486-2024
Recall number
D-0486-2024
Initiated
April 08, 2024
Classification
Class I
Status
Ongoing
Quantity
2402 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sub-potent Drug; powder discoloration associated with decreased potency

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Sub-potent Drug; powder discoloration associated with decreased potency

Code information

Lot # T2200352, Exp. 12/31/2024

Distribution pattern

Nationwide in the USA