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.

Class III · Low risk

AcneFree Original Strength Terminator

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Terminated Wrong potency / content Valeant Pharmaceuticals D-045-2013
Class III · Low risk

AcneFree Oil-Free Acne Cleanser

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Terminated Wrong potency / content Valeant Pharmaceuticals D-044-2013
Class III · Low risk

AcneFree 24 Hour Clearing System containing 1-count 4 fl oz

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Terminated Wrong potency / content Valeant Pharmaceuticals D-042-2013
Class I · High risk

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS

Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

Ongoing Wrong potency / content Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals NDC 0603-3888-21 D-057-2013
Class I · High risk

BiCNU (Carmustine for injection)

Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.

Terminated Wrong potency / content Bristol-myers Squibb Company NDC 0015-3012-18 D-012-2013
Class I · High risk

HYDROmorphone HCl Injection

Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.

Terminated Wrong potency / content Hospira Inc. NDC 0409-1312-30 D-020-2013
Class II · Moderate risk

Levothroid

Subpotent; 9-month stability interval

Terminated Wrong potency / content Lloyd Inc. of Iowa NDC 0456-1322-01 D-103-2013
Class II · Moderate risk

Levothroid

Subpotent; 9-month stability interval

Terminated Wrong potency / content Lloyd Inc. of Iowa NDC 0456-1321-01 D-101-2013
Class II · Moderate risk

Mylan

Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

Terminated Wrong potency / content Mylan LLC. NDC 0378-2045-01 D-066-2013
Class II · Moderate risk

Little Remedies For Tummys

Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.

Terminated Wrong potency / content Medtech Products, Inc. D-1673-2012
Class I · High risk

HYDROmorphone HCl Injection

Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.

Terminated Wrong potency / content Hospira Inc. NDC 0409-1283-31 D-1444-2012