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.
What this means for you
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
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