Recalls / Class II
Class IID-0546-2025
Product
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
- Brand name
- Cinacalcet
- Generic name
- Cinacalcet
- Active ingredient
- Cinacalcet Hydrochloride
- Route
- Oral
- NDCs
- 64380-883, 64380-884, 64380-885
- FDA application
- ANDA209226
- Affected lot / code info
- Lot #: 7715893A, Exp. Date 12/31/2027
Why it was recalled
Failed Dissolution Specifications.
Recalling firm
- Firm
- Strides Pharma, Inc.
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 6,672 bottles
- Distribution pattern
- Product was distributed nationwide within the United States
Timeline
- Recall initiated
- 2025-07-09
- FDA classified
- 2025-07-30
- Posted by FDA
- 2025-08-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0546-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.