Cipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit
Cipla is recalling Cinacalcet Hydrochloride Tablets, 30 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 113,336 bottles are affected.
What this means for you
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: FDA Class II recall for an impurity above its acceptable daily intake limit, a product-quality failure creating risk of harm with no injuries reported.
Plain-English summary
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 30 mg, supplied in bottles of 30 tablets, NDC 69097-410-02. The product is manufactured by Cipla Ltd. in Patalganga, India. The action covers 113,336 bottles.
The stated reasons are current good manufacturing practice deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. Nitrosamine impurities are controlled to defined intake limits because of their potential for long-term harm. The FDA classified the action as Class II.
Affected lots are 4PB0526, 4PB0527 and 4PB0528 (expiry September 2026) and 5PB0173 (expiry January 2027). Distribution was nationwide in the USA.
This is a prescription medicine. Patients should not stop taking a prescribed course without medical advice; anyone holding an affected lot should contact their pharmacy or prescriber about a replacement supply.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Oral tablet
- Affected units
- 113,336
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 (7)
- Lot
- expiry: Lot 4PB0526
- 4PB0527
- 4PB0528
- exp September-2026
- Lot 5PB0173
- exp January-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
Same brand · CINACALCET
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- SevereCinacalcet Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2026-07-08
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits
FDA (Drugs) · 2026-07-08
- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
Same manufacturer · Cipla USA, Inc.
See all →- HighCipla lanreotide prefilled syringes recalled over visual inspection deficiencies
FDA (Drugs) · 2026-04-15
- HighCipla lanreotide syringes with safety needle recalled over sterility assurance
FDA (Drugs) · 2026-04-15
Same hazard · nitrosamine impurity
See all →- HighEnovachem duloxetine capsules exceed the nitrosamine acceptable intake limit
FDA (Drugs) · 2026-06-10
- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride further lots recalled over nitrosamine impurity levels
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride tablets recalled over nitrosamine impurity above limits
FDA (Drugs) · 2026-04-08
- HighAmneal tramadol tablets failed nitrosamine impurity specification at stability
FDA (Drugs) · 2026-04-08