FDA Drugs recall ·
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only… recall
- Recall number
- D-0546-2025
- Date
- (initiated July 9, 2025)
- Company / brand
- Strides Pharma, Inc.
1 Ram Ridge Rd, Chestnut Ridge, NY, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6,672 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Dissolution Specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 7715893A, Exp. Date 12/31/2027
Distribution
Product was distributed nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0546-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.