Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 recalls, newest first.

Class II · Moderate risk

LX Bioboost Plus

Lack of Assurance of Sterility

Ongoing Sterility / contamination Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) D-0477-2025
Class II · Moderate risk

Theophylline

OOS results reported for the Dissolution (by UV) test.

Ongoing Dissolution failure Glenmark Pharmaceuticals Inc., USA D-0452-2025
Class II · Moderate risk

BD ChloraPrep Clear

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Ongoing Sterility / contamination CareFusion 213, LLC NDC 54365-400-31 D-0441-2025
Class II · Moderate risk

Celecoxib Capsules

Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

Ongoing Particulate / foreign matter AvKARE NDC 50268-169-15 D-0460-2025
Class II · Moderate risk

Celecoxib Capsules

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

Ongoing Particulate / foreign matter Alembic Pharmaceuticals Limited NDC 62332-142-71 D-0459-2025
Class II · Moderate risk

temper tamer

CGMP Deviations

Ongoing cGMP deviation Siddha Flower Essences, LLC. NDC 69779-020-01 D-0410-2025
Class II · Moderate risk

Infuvite Adult

Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.

Ongoing Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office NDC 54643-5649-1 D-0401-2025

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