Quality & complianceOfficial

AvKARE amitriptyline hydrochloride recall classed Class II over failed dissolution specifications

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

The FDA's enforcement report lists an ongoing nationwide US recall of AvKARE's amitriptyline hydrochloride after the product failed dissolution specifications.

The US Food and Drug Administration has published a Class II drug recall for amitriptyline hydrochloride supplied by AvKARE in its enforcement report dated 28 October 2026. The stated reason is failed dissolution specifications.

The recall is recorded as ongoing, and distribution is described as US nationwide. The material available to us does not include the product strengths, lot numbers, expiry dates, quantities or the date the recall began, so the affected batches cannot be identified from this item.

As general 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. A dissolution failure means the product did not release its active ingredient within the limits set in its specification.

What it means for your team

  • Wholesalers, pharmacies and distributors handling AvKARE amitriptyline should check the full FDA enforcement report entry for the affected lots and recall instructions.
  • Quality teams at other manufacturers may wish to note dissolution failure as a continuing driver of US generic drug recalls.
  • Pharmacovigilance teams should be aware of the recall in case product-quality complaints for amitriptyline arise, though the source gives no information on adverse events.

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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