Quality & complianceOfficial

FDA lists Class II recall of Apothecary Pharma's tirzepatide injection over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The enforcement report entry, numbered D-0036-2027, cites lack of assurance of sterility and records the nationwide recall as ongoing.

The US Food and Drug Administration has classified a recall of Tirzepatide Injection from Apothecary Pharma LLC as Class II. The entry appears in the agency's enforcement report dated 14 October 2026 and carries recall number D-0036-2027.

The stated reason is a lack of assurance of sterility. The record does not say whether any contamination was actually found, so the entry should be read as a failure to demonstrate sterility rather than as a confirmed microbial finding.

The recall is listed as ongoing, with distribution nationwide within the United States. The material available does not include lot numbers, quantities, strengths, dates of distribution or the level to which the recall was conducted, nor does it describe any reported adverse events.

For 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

  • Quality teams should treat sterility assurance lapses in injectable products as a recurring enforcement theme and check aseptic processing and sterility testing records accordingly.
  • Pharmacovigilance and medical information teams may want to monitor for reports involving this product, given the nationwide distribution.
  • Anyone handling or distributing the product should consult the full FDA enforcement report entry for lot details, which are not included in the summary available here.

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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