Cinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a prescription drug with an impurity (N-nitroso compound) above acceptable intake thresholds. Per the rubric, FDA Class II with manufacturing deviations that pose potential health risk meets the Severe criterion, even though no illnesses have been reported.
Plain-English summary
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottles (NDC 69097-412-02) due to current Good Manufacturing Practice (cGMP) deviations. The recalled lot (Lot #5PB0563, expiration date 4/30/2027) contains N-nitroso-cinacalcet at levels above the acceptable daily intake.
Cinacalcet is a prescription medication used to treat certain conditions related to calcium and parathyroid hormone levels. Patients currently taking this product should not stop taking their medication without consulting their healthcare provider. Consumers with questions or who have experienced any adverse effects should contact their healthcare provider or pharmacist.
The product was distributed nationwide. Cipla USA, Inc., located at 10 Independence Boulevard, Suite 300, Warren, NJ 07059, is conducting this recall. The FDA has classified this as a Class II recall.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Prescription Tablet
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 #: 5PB0563
- Exp 4/30/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Cipla USA, Inc. 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
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Same manufacturer · Cipla USA, Inc.
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Same hazard · impurity
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Similar recalls
- HighCinacalcet 90 mg tablets recalled over a nitrosamine impurity above limits
FDA (Drugs) · 2025-12-17
- HighCinacalcet 30 mg tablets recalled over a nitrosamine impurity above limits
FDA (Drugs) · 2025-12-17
- HighCipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit
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- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- SevereCinacalcet 60 mg tablets recalled over a nitrosamine impurity above limits
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- HighCipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit
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