Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Wrong potency or content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk.

992 FDA drug recalls with this cause, newest first.

These recalls cover sub-potent or super-potent products, or a failed content-uniformity test - meaning some pills in the same batch held noticeably different amounts of active ingredient than others. Either way it is a direct dosing risk: too little to work, or too much and harmful. Thyroid hormones and compounded injectables are the classic examples, because their dose window is narrow.

Total recalls
992
Class I (high risk)
84
Currently ongoing
169
Most recent
Aug 31, 2026

Most-cited firms for this cause

  • Medline Industries Inc70
  • TG United, Inc.44
  • Pharmedium Services, LLC28
  • Accord Healthcare, INC.26
  • RLC Labs Inc.24
  • Ohm Laboratories, Inc.22
  • Lupin Pharmaceuticals Inc.17
  • Hill Dermaceuticals, Inc.16
Class II · Moderate risk

Lidocaine Ointment USP

Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

Ongoing Wrong potency / content Sun Pharma /Taro D-0848-2026