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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
February 12, 20141 recall
December 4, 20131 recall
November 27, 20134 recalls
RecallClassStatus
Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-946-16, UPC 0 41260 35832 6Class IITerminatedAcetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2Class IITerminatedAcetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-590-16, UPC 3 70030 62529 1; c) equate Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-590-16, UPC 6 81131 00185 4; d) Meijer Infants' Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, NDC 41250-590-16, UPC 7 13733 31376 6; e) Walgreens infants' Dye-Free Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0590-16, UPC 3 11917 13222 8; f) Kroger Infants' Pain & Fever suspension liquid, 4 FL OZ (118 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-26, UPC 0 41260 36738 0; g) Kroger Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-16, UPC 0 41260 35829 6; h) Publix Infants' painrelief acetaminophen suspension liquid, 2 FL OZ (59 mL), Distributed By Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 55062-590-16, UPC 0 41415 39573 2; i) CareOne Infants' Dye-Free Pain Relief acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed By Foodhold U.S.A., LLC, Landover, MD 20785, NDC 41520-590-16, UPC 3 41520 31006 5; j) Harmon FaceValues Infants' Pain & Fever acetaminophen suspension Liquid, 2 FL OZ (59 mL), Distributed by Harmon Stores, Inc., 650 Liberty Ave., Union, NJ 07083 USA, UPC 3 70030 51018 4Class IITerminatedAcetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7Class IITerminatedOctober 30, 20131 recall
September 25, 20131 recall
August 14, 20132 recalls
RecallClassStatus
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01Class IITerminatedMethylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01Class IITerminatedRecalls by condition
- Blood pressure medication recalls36 activeLisinopril, Losartan, Amlodipine, Valsartan
- Cholesterol medication recalls10 activeAtorvastatin, Rosuvastatin, Simvastatin
- Diabetes drug recalls20 activeMetformin, Insulin Glargine, Sitagliptin
- ADHD medication recalls0 activeAmphetamine, Methylphenidate, Atomoxetine
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.