Quality & complianceOfficial

FDA lists Class II recall of MSN atorvastatin tablets over foreign tablets or capsules

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

An FDA enforcement report entry classifies a nationwide US recall of atorvastatin calcium tablets from MSN Laboratories' Unit-II as Class II, citing the presence of foreign tablets or capsules.

The US Food and Drug Administration has published a Class II drug recall entry for atorvastatin calcium tablets made by MSN Laboratories Private Limited, Formulations Division, Unit-II. The entry appears in the agency's enforcement report dated 4 November 2026 under recall number D-0113-2027.

The stated reason for the recall is the presence of foreign tablets or capsules. The record shows the recall as ongoing, and distribution as nationwide in the United States.

The text available for this article is mostly the navigation and search interface of the FDA database. It does not include product strengths, lot numbers, expiry dates, quantities, the identity of the recalling firm if different from the manufacturer, or details of how the foreign material was discovered. Those details would normally sit in the full enforcement report record.

As context, the 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 harm is remote.

What it means for your team

  • Quality teams with atorvastatin from MSN Unit-II in their supply chain should check the full FDA record for lot and strength details to establish whether their stock is affected.
  • Pharmacovigilance teams may wish to watch for complaints about mixed or unexpected tablets or capsules in atorvastatin packs.
  • Market-access and supply teams should note the recall is ongoing and nationwide in the US, so continuity-of-supply planning may be relevant.

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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