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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95500

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

Open FDA event record

Event summary

Timeline bucket
October 09, 2024
Product types
Drug
Classifications
Class II
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

3 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 3

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

D-0026-2025
Recall number
D-0026-2025
Initiated
October 09, 2024
Classification
Class II
Status
Ongoing
Quantity
285126 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso Cinacalcet impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Code information

Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202741, & T2202740, Exp 06/2025; T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, Exp 07/2025; T2300770, T2300771, T2300769, T2300766, T2300767 & T2300768, Exp 12/2025 Lots T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658 & T2301659, Exp Date 02/2026 Lots T2304704, T2304703, T2304705, T2304706, Exp Date 08/2026 Lots T2400468, T2400469, T2400473 & T2400474 Exp Date 11/2026

Distribution pattern

USA Nationwide.

drug · product 2 of 3

Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

D-0027-2025
Recall number
D-0027-2025
Initiated
October 09, 2024
Classification
Class II
Status
Ongoing
Quantity
35880 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso Cinacalcet impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Code information

Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026.

Distribution pattern

USA Nationwide.

drug · product 3 of 3

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

D-0028-2025
Recall number
D-0028-2025
Initiated
October 09, 2024
Classification
Class II
Status
Ongoing
Quantity
10584 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso Cinacalcet impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Code information

Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.

Distribution pattern

USA Nationwide.