Quality & complianceOfficial

FDA lists Class II recall of Strides Pharma cinacalcet tablets over failed dissolution specifications

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

The recall, numbered D-0079-2027, covers cinacalcet tablets from Strides Pharma Inc, is ongoing and was distributed across the US.

The US Food and Drug Administration has published a Class II recall of Cinacalcet Tablets from Strides Pharma Inc in its enforcement report dated 28 October 2026. The event is recorded under recall number D-0079-2027.

The stated reason is failed dissolution specifications. In practice, this means the product did not meet the dissolution requirements applied to the tablets, which is a quality attribute linked to how a medicine releases its active ingredient.

The enforcement report lists the recall status as ongoing, and the distribution pattern as US nationwide. The material available does not include further details such as lot numbers, quantities, expiry dates or the date the recall began, so the scale of the affected product cannot be assessed from this entry.

As general context, FDA assigns Class II to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

What it means for your team

  • Quality and supply teams handling cinacalcet tablets should check the full FDA enforcement report entry for lot and code information, which was not available in the source text reviewed.
  • Dissolution failures remain a recurring reason for oral solid dose recalls, reinforcing the importance of dissolution testing in release and stability programmes.
  • Wholesalers and pharmacies in the US should verify stock against the recall details, given the nationwide distribution and ongoing status.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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