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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 6, 20212 recalls
RecallClassStatus
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88Class IITerminatedAscend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68Class IITerminatedNovember 11, 20205 recalls
RecallClassStatus
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60Class IITerminatedTime-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50Class IITerminatedTime-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01Class IITerminatedMetformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90Class IITerminatedmetformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127Class IITerminatedSeptember 30, 20201 recall
September 16, 20202 recalls
RecallClassStatus
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.Class IITerminatedCephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.Class 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.