CLASS II ONGOING Drug recall · Reported 22 Apr 2026 · FDA Enforcement Report

Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USA

Cipla USA is recalling Cinacalcet Hydrochloride Tablets, 30 mg per, distributed nationwide in the US. The recall was initiated on 16 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027

NDC69097-410, 69097-411, 69097-412

Quantity recalled113,336 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0449-2026
FDA event ID: 98670
Recalling firm: Cipla USA, Warren, NJ
Brand: Cinacalcet
Manufacturer: Cipla USA Inc.
Classification: Class II
Status: Ongoing
Recall initiated: 16 Mar 2026
FDA classified: 10 Apr 2026
Reported: 22 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity

Timeline

16 Mar 2026	Recall initiated by company
10 Apr 2026	Classified by FDA	+25 days
22 Apr 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

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 was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Which lots are affected?

Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 98670

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
22 Apr 2026	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide

More recalls from Cipla USA

All 23

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
22 Apr 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
22 Apr 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide

Other Cinacalcet recalls

All 30

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
1 Jul 2026Drug	CLASS II	Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar	Amgen	Manufacturing (CGMP) Deviations	Nationwide
1 Jul 2026Drug	CLASS II	Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar	Amgen	Manufacturing (CGMP) Deviations	Nationwide