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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

July 6, 20224 recalls

RecallClassStatus
Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · PD-Rx Pharmaceuticals, Inc. · 1320 bottlesClass IITerminatedLosartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · PD-Rx Pharmaceuticals, Inc. · 687 bottlesClass IITerminatedLosartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits · PD-Rx Pharmaceuticals, Inc. · 1441 bottlesClass IITerminatedDaytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3Defective Delivery System: Customer complaints received for ripping patches and tight… · Noven Pharmaceuticals Inc · 8,559 cartonsClass IIOngoing

June 15, 20226 recalls

RecallClassStatus
Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05cGMP deviations: Temperature abuse · Mckesson Medical-Surgical Inc. Corporate Office · 7 bottlesClass IITerminatedDiphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose cups (NDC 0121-0978-10), b) 100-count box (NDC 0121-0978-00), Rx only, MFG: Pharmaceutical Associates Inc.cGMP deviations: Temperature abuse · Mckesson Medical-Surgical Inc. Corporate Office · 1 case/100 unit dose cupsClass IITerminatedAzithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10cGMP deviations: Temperature abuse · Mckesson Medical-Surgical Inc. Corporate Office · 13 carton/10 vials eachClass IITerminatedAlbuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85cGMP deviations: Temperature abuse · Mckesson Medical-Surgical Inc. Corporate Office · 1 aerosolClass IITerminatedAlbuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG by: Nephron Pharma, NDC 0487-9501-25cGMP deviations: Temperature abuse · Mckesson Medical-Surgical Inc. Corporate Office · 96 pouchesClass IITerminatedAlbuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03cGMP deviations: Temperature abuse · Mckesson Medical-Surgical Inc. Corporate Office · 23 pouchesClass 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.