thejoe Cinacalcet

Cinacalcet recalls: 17 FDA reports

Recalls involving Cinacalcet. What was wrong with each batch, and how the FDA graded the risk.

17Reports

0Class I

16Ongoing

2026-07-08Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	17

By year reported

Year	Reports
2024	7
2025	4
2026	6

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalgan

D-0661-2026 · Class II · reported 2026-07-08 · Ongoing

Why it was recalled: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Product: Cinacalcet Hydrochloride Tablets, 30 mg, 30-count 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
Where it went: USA Nationwide
How much: 31,824 bottles

Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalgan

D-0676-2026 · Class II · reported 2026-07-08 · Ongoing

Why it was recalled: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Product: Cinacalcet Hydrochloride Tablets, 90 mg, 30-count 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
Where it went: USA Nationwide
How much: N/A

Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalgan

D-0675-2026 · Class II · reported 2026-07-08 · Ongoing

Why it was recalled: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Product: Cinacalcet Hydrochloride Tablets, 60 mg, 30-count 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
Where it went: USA Nationwide
How much: N/A

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Pa

D-0449-2026 · Class II · reported 2026-04-22 · Ongoing

Why it was recalled: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product: 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
Where it went: Nationwide in the USA
How much: 113,336 bottles

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Pa

D-0451-2026 · Class II · reported 2026-04-22 · Ongoing

Why it was recalled: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product: 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
Where it went: Nationwide in the USA
How much: 63,192 bottles

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Pa

D-0450-2026 · Class II · reported 2026-04-22 · Ongoing

Why it was recalled: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product: 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
Where it went: Nationwide in the USA
How much: 96,096 bottles

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10

D-0226-2026 · Class II · reported 2025-12-17 · Ongoing

Why it was recalled: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product: 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
Where it went: Nationwide in the US
How much: 12,576 bottles

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10

D-0224-2026 · Class II · reported 2025-12-17 · Ongoing

Why it was recalled: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product: 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
Where it went: Nationwide in the US
How much: 63,504 bottles

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10

D-0225-2026 · Class II · reported 2025-12-17 · Ongoing

Why it was recalled: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product: 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
Where it went: Nationwide in the US
How much: 15,744 bottles

Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry,

D-0546-2025 · Class II · reported 2025-08-06 · Ongoing

Why it was recalled: Failed Dissolution Specifications.
Product: Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
Where it went: Product was distributed nationwide within the United States
How much: 6,672 bottles

Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC

D-0032-2025 · Class II · reported 2024-11-06 · Ongoing

Why it was recalled: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product: Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Where it went: Nationwide in the USA and PR
How much: N/A

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made i

D-0028-2025 · Class II · reported 2024-11-06 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product: Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Where it went: USA Nationwide.
How much: 10584 bottles

Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC

D-0031-2025 · Class II · reported 2024-11-06 · Ongoing

Why it was recalled: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product: Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Where it went: Nationwide in the USA and PR
How much: N/A

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

D-0027-2025 · Class II · reported 2024-11-06 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product: Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Where it went: USA Nationwide.
How much: 35880 bottles

Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC:

D-0030-2025 · Class II · reported 2024-11-06 · Ongoing

Why it was recalled: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product: Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Where it went: Nationwide in the USA and PR
How much: N/A

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made i

D-0026-2025 · Class II · reported 2024-11-06 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product: Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
Where it went: USA Nationwide.
How much: 285126 bottles

Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc.,

D-0263-2024 · Class II · reported 2024-01-31 · Completed

Why it was recalled: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Product: Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
Where it went: Nationwide in the USA
How much: 1,728 bottles

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

← All drug recalls