Cinacalcet Tablets Recalled for Elevated Nitrosamine Impurity
AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for pharmaceutical contamination (nitrosamine impurity) with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not been reported score at a maximum of High (3).
Plain-English summary
AvKARE is recalling Cinacalcet Tablets, 60 mg, in 30-count bottles. The affected lot is #44550, with an expiration date of 12/31/2024. A total of 2,396 bottles were distributed nationwide.
The recall is due to Current Good Manufacturing Practices (CGMP) deviations identified during manufacturing. Testing detected the presence of N-Nitroso-Cinacalcet, a nitrosamine impurity, at levels exceeding the acceptable intake limit.
Patients who possess this medication should contact their pharmacist or healthcare provider for guidance regarding this recall.
The recalled product
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 44550
- Exp 12/31/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by AvKARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · AvKARE
See all →- HighAmantadine hydrochloride capsules recalled after failing dissolution specifications
FDA (Drugs) · 2026-03-04
- ModerateRosuvastatin tablets recalled after failing a dissolution specification
FDA (Drugs) · 2026-01-14
- HighOral contraceptive tablets recalled after failing content uniformity specifications
FDA (Drugs) · 2025-10-15
- HighAvKare chlorpromazine 100 mg cartons recalled over presence of foreign substance
FDA (Drugs) · 2025-09-17
- HighAvKare chlorpromazine unit dose cartons recalled over presence of foreign substance
FDA (Drugs) · 2025-09-17
Same hazard · nitrosamine
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
FDA (Drugs) · 2026-02-11
- HighClomipramine 25 mg capsules recalled over nitrosamine above the intake limit
FDA (Drugs) · 2025-11-12
Similar recalls
- HighCinacalcet Tablets Recalled Due to Nitrosamine Impurity
FDA (Drugs) · 2024-11-06
- HighCinacalcet 30 mg tablets recalled over a nitrosamine impurity above limits
FDA (Drugs) · 2025-12-17
- HighCinacalcet 90 mg tablets recalled over a nitrosamine impurity above limits
FDA (Drugs) · 2025-12-17
- HighCinacalcet tablets recalled for manufacturing impurity exceeding FDA limits
FDA (Drugs) · 2024-11-06
- SevereCinacalcet 60 mg tablets recalled over a nitrosamine impurity above limits
FDA (Food) · 2025-12-17
- HighAccord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Contamination
FDA (Drugs) · 2024-11-06