Why it was recalled
Failed Dissolution Specifications.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 7715893A, Exp. Date 12/31/2027
Where it was sold
Product was distributed nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0546-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 9, 2025
- FDA report date
- Aug 6, 2025
- Quantity
- 6,672 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Strides Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0546-2025, exactly as published.
Show all FDA fields
- City
- Chestnut Ridge
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 97215
- Address
- 1 Ram Ridge Rd
- Code information
- Lot #: 7715893A, Exp. Date 12/31/2027
- Postal code
- 10977-6714
- Report date
- Aug 6, 2025
- Product type
- Drugs
- Recall number
- D-0546-2025
- Classification
- Class II
- Recalling firm
- Strides Pharma, Inc.
- Product quantity
- 6,672 bottles
- Reason for recall
- Failed Dissolution Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed nationwide within the United States
- Recall initiation date
- Jul 9, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 30, 2025