Prescription Drug Cinacalcet Tablets Recalled for Manufacturing Contamination
Sun Pharmaceutical is recalling 1,728 bottles of Cinacalcet Tablets 60mg due to microbial contamination found in manufacturing equipment. No illnesses have been reported.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II recall for manufacturing facility microbial contamination without reported illnesses, injuries, or identified specific high-risk pathogens.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 1,728 bottles of Cinacalcet Tablets 60mg (Lot DNE0702A, expiring 06/30/2026) distributed nationwide in the United States. The recall was issued due to a Current Good Manufacturing Practice (CGMP) deviation discovered in the manufacturing facility.
Microbial contamination was detected in stagnant water in a duct of the manufacturing equipment. The product is a prescription-only medication manufactured by Sun Pharmaceutical Industries Limited in India and distributed by Sun Pharmaceutical Industries Inc., Cranbury, New Jersey.
No illnesses or injuries related to the use of this product have been reported.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Hazard
- Affected units
- 1,728
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 #: DNE0702A
- Exp. 06/30/2026
UPCs (1)
- 0347335600834
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by SUN PHARMACEUTICAL INDUSTRIES 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 11 products in this recall →Related recalls
Same brand · CINACALCET
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits
FDA (Drugs) · 2026-07-08
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- SevereCinacalcet Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2026-07-08
- HighCipla cinacalcet 30 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 · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
Same hazard · microbial contamination
See all →- SevereMedtronic Recalls Grafton DBM Allografts Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- HighCinacalcet tablets recalled for manufacturing impurity exceeding FDA limits
FDA (Drugs) · 2024-11-06
- HighCinacalcet Tablets Recalled Due to Nitrosamine Impurity
FDA (Drugs) · 2024-11-06
- HighPrescription Drug Recall: Cinacalcet Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-11-06
- HighCinacalcet 30 mg tablets recalled over a nitrosamine impurity above limits
FDA (Drugs) · 2025-12-17
- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCinacalcet tablets recalled for nitroso impurity above FDA limits
FDA (Drugs) · 2024-11-06