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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97974

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

Open FDA event record

Event summary

Timeline bucket
November 14, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cipla USA, 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 Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02

D-0224-2026
Recall number
D-0224-2026
Initiated
November 14, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cipla USA, Inc.
Quantity
63,504 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
nitrosamine 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: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Code information

Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027

Distribution pattern

Nationwide in the US

drug · product 2 of 3

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

D-0225-2026
Recall number
D-0225-2026
Initiated
November 14, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cipla USA, Inc.
Quantity
15,744 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
nitrosamine 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: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Code information

Lot 5PB0164, exp 1/31/2027

Distribution pattern

Nationwide in the US

drug · product 3 of 3

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02

D-0226-2026
Recall number
D-0226-2026
Initiated
November 14, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cipla USA, Inc.
Quantity
12,576 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
nitrosamine 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: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Code information

Lot 5PB0183, exp 1/31/2027

Distribution pattern

Nationwide in the US