Cinacalcet Tablets 90 mg recall
FDA recall D-0546-2025 · initiated Jul 9, 2025
Strides Pharma, Inc. recalled Cinacalcet Tablets 90 mg in Jul 2025 — an FDA Class II recall (D-0546-2025) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,672 bottles
Details
- 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
- Recalling company
- Strides Pharma Intl
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Jul 9, 2025
- FDA report date
- Aug 6, 2025
Frequently asked
- Was Cinacalcet Tablets 90 mg recalled?
- Strides Pharma, Inc. recalled Cinacalcet Tablets 90 mg in Jul 2025 — an FDA Class II recall (D-0546-2025) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cinacalcet Tablets 90 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0546-2025 was: Failed Dissolution Specifications.
- Is a recalled Cinacalcet Tablets 90 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cinacalcet Tablets 90 mg are affected?
- Distributed: Product was distributed nationwide within the United States. The recall covers these lots — Lot #: 7715893A, Exp. Date 12/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0546-2025.