Skip to content
Back to recalls
Drug FDA Class II Ongoing Failed specifications

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

Strides Pharma, Inc. Published Aug 6, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Strides Pharma, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications.

Hazards

Failed Dissolution · primary

Affected products (1)

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

CINACALCET · 6,672 bottles

NDC: 64380-883, 64380-884, 64380-885, 64380-883-04, 64380-884-04, 64380-885-04
Code info: Lot #: 7715893A, Exp. Date 12/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 9, 2025
  2. Published
    Aug 6, 2025
Recall number
D-0546-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.