Quality & complianceOfficial

FDA lists Class II recall of testosterone cypionate over lack of sterility assurance

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

Right Value Drug Stores LLC's nationwide recall of testosterone cypionate, numbered D-0070-2027, is classed as Class II and remains ongoing, according to the FDA enforcement report.

The US Food and Drug Administration has published a Class II recall of testosterone cypionate from Right Value Drug Stores LLC in its enforcement report dated 28 October 2026. The reason given is a lack of sterility assurance.

The recall is numbered D-0070-2027 and its status is listed as ongoing. The product was distributed nationwide in the USA.

The text available for this item is a navigation and search page for the enforcement report database. It gives no product strengths, lot numbers, expiry dates, quantities or details of how the sterility concern arose, so those points cannot be reported here.

As context, the FDA assigns Class II to recalls where use of or exposure to a 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

  • Pharmacies, wholesalers and prescribers handling testosterone cypionate from this firm should check the full FDA enforcement report entry for lot and code details.
  • Quality teams should note that a lack of sterility assurance remains a common trigger for injectable product recalls, and review related supplier and aseptic-processing controls.
  • Pharmacovigilance teams may wish to watch for any adverse event reports linked to the affected product, though none are cited in the source.

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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