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Drug recalls, by class and condition

Every Class I, II, and III recall from the FDA Enforcement Report database, in chronological order. Class I is the most serious.

In the last 30 days, FDA issued 1 Class I recall (most serious), 16 Class II, and 8 Class III affecting the medications we cover.

Sourced from FDA Enforcement Reports. Verify on FDA →

Verified from FDA on 06-03-2026 16:11 ETRefreshes every 6 hoursFDA-Sourced

All Class I Class II Class III Ongoing only

Sort by:Most recentMost severe

August 27, 20251 recall

RecallClassStatus

Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above… · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 26,628 cartonsClass IIOngoing

August 20, 20259 recalls

RecallClassStatus

Recalls by condition

Most-affected drugs:Levothyroxine 37 Duloxetine 22 Cinacalcet 16 Carvedilol 13 Acetaminophen 12

How FDA classifies recalls

Class I: The drug may cause serious health consequences or death. Examples include the wrong drug in a bottle, a drug contaminated with bacteria, or a life-threatening allergen not declared on the label.

Class II: The drug may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote. Examples include a dissolution failure, a labeling error that affects dosing, or a nitrosamine impurity above the daily intake limit.

Class III: Use of the drug is unlikely to cause adverse health consequences, but the product violates FDA regulations. Examples include an incorrect tablet count per bottle, minor labeling issues, or packaging defects.

Definitions sourced from FDA Recall Classifications →

Frequently Asked Questions

What is the difference between Class I, II, and III drug recalls?

FDA classifies recalls by health risk. Class I means the drug can cause serious harm or death. Class II means temporary or reversible adverse health consequences are possible. Class III means the recall is unlikely to cause harm but the product violates FDA regulations.

How often is the FDA recall list updated?

FDA publishes the Enforcement Report weekly. MedivaScan refreshes from openFDA every 6 hours, so new recalls typically appear here within hours of FDA posting them.

What should I do if my medication appears on this list?

Contact a pharmacist or prescriber for guidance. Do not stop taking a medication based on a recall notice alone. The prescriber will advise on substitutes or whether the specific lot affects you. Each recall row links to a drug detail page with the affected lot range and the FDA product description.

Where does the recall data come from?

All data is sourced from the FDA Drug Enforcement Report endpoint via openFDA. Each row links to the canonical FDA notice for verification. MedivaScan does not add, modify, or interpret FDA's underlying record.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.