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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 Refreshes every 6 hoursFDA-Sourced

January 3, 202410 recalls

RecallClassStatus
Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. · Legacy Pharmaceutical Packaging LLC · 161,664 bottlesClass IIOngoingMetoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage… · CARDINAL HEALTHCARE · 1 unitClass IITerminatedAMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage… · CARDINAL HEALTHCARE · 3 unitsClass IITerminatedJardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage… · CARDINAL HEALTHCARE · 1 unitClass IITerminatedALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage… · CARDINAL HEALTHCARE · 2 cartonsClass IITerminatedAripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage… · CARDINAL HEALTHCARE · 2 unitsClass IITerminatedALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage… · CARDINAL HEALTHCARE · 11 cartonsClass IITerminatedWarfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage… · CARDINAL HEALTHCARE · 1 unitClass IITerminatedWarfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage… · CARDINAL HEALTHCARE · 1 unitClass IITerminatedESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage… · CARDINAL HEALTHCARE · 1 unitClass IITerminated

Recalls by condition

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.