Cinacalcet Tablet
FDA Recall NDC 69097-412
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Cinacalcet (NDC 69097-412). A significant event, classified as Class II, was initiated on Mar 16, 2026 by Cipla Usa Inc.. The reported reason for this action was: "CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
March 2026 Class II Recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Recall Number
Class II Ongoing
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Mar 16, 2026
Apr 22, 2026
63,192 bottles
Recall Profile & Regulatory Data
Event ID
98670
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
Batch or Lot Expiration Information
Lot# Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027
Affected Packages Involved in this Recall
69097-410-02Product
69097-411-02Product
69097-412-02Product
March 2026 Class II Recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Recall Number
Class II Ongoing
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Mar 16, 2026
Apr 22, 2026
113,336 bottles
Recall Profile & Regulatory Data
Event ID
98670
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027
Affected Packages Involved in this Recall
69097-410-02Product
69097-411-02Product
69097-412-02Product
March 2026 Class II Recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Recall Number
Class II Ongoing
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Mar 16, 2026
Apr 22, 2026
96,096 bottles
Recall Profile & Regulatory Data
Event ID
98670
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Batch or Lot Expiration Information
Lot# Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
Affected Packages Involved in this Recall
69097-410-02Product
69097-411-02Product
69097-412-02Product
Class II Ongoing
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Nov 14, 2025
Dec 17, 2025
63,504 bottles
Recall Profile & Regulatory Data
Event ID
97974
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
Affected Packages Involved in this Recall
69097-410-02Product
69097-411-02Product
69097-412-02Product
Class II Ongoing
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Nov 14, 2025
Dec 17, 2025
15,744 bottles
Recall Profile & Regulatory Data
Event ID
97974
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
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
Batch or Lot Expiration Information
Lot# Lot 5PB0164, exp 1/31/2027
Affected Packages Involved in this Recall
69097-410-02Product
69097-411-02Product
69097-412-02Product
Class II Ongoing
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Nov 14, 2025
Dec 17, 2025
12,576 bottles
Recall Profile & Regulatory Data
Event ID
97974
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
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
Batch or Lot Expiration Information
Lot# Lot 5PB0183, exp 1/31/2027
Affected Packages Involved in this Recall
69097-410-02Product
69097-411-02Product
69097-412-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
