Strides Pharma recalls 90mg Cinacalcet tablets with failed dissolution specs. Rx-only bottles may not work as intended. Check NDC 64380-885-04 and lot 7715893A for affected units.
“Strides Pharma Cinacalcet Tablets 90mg Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31993-strides-pharma-cinacalcet-tablets-90mg-recall-failed-dissolution-specifications. Based on FDA recall #D-0546-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0546-2025%22&limit=1).
Strides Pharma Inc. voluntarily recalled Cinacalcet Tablets 90 mg due to failed dissolution specifications, the FDA announced on July 9, 2025. The recall affects 6,672 bottles distributed nationwide.
The product failed dissolution specifications, according to the FDA.
Context
GovInfoNow's records show Strides Pharma Inc. has 9 other recalls on record since May 9, 2017. Other recent recalls of similar products include Taro Recalls Children's Ibuprofen (March 2, 2026), Strides Pharma Recalls Testosterone Gel (March 5, 2025), and Strides Pharma recalls Methoxsalen Capsules (December 29, 2023).
How to tell if you have this one
Check for the NDC code 64380-885-04 on the bottle label. The lot number 7715893A and expiration date 12/31/2027 are also on the packaging.
Brand
Strides Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC 64380-885-04 and lot number 7715893A on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0546-2025 (July 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0546-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.