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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), 10 Class II, and 2 Class III affecting the medications we cover.

Sourced from FDA Enforcement Reports. Verify on FDA →

Verified from FDA on Refreshes every 6 hoursFDA-Sourced

December 11, 20244 recalls

RecallClassStatus
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim… · Glenmark Pharmaceuticals Inc., USA · 34848 bottlesClass IIOngoingDiltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim… · Glenmark Pharmaceuticals Inc., USA · 12,864 bottlesClass IIOngoingLevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17Subpotent drug · ACCORD HEALTHCARE, INC.Class IIOngoingCinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit · Aurobindo Pharma USA IncClass IIOngoing

November 27, 20241 recall

November 6, 20245 recalls

RecallClassStatus
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable… · ACCORD HEALTHCARE, INC. · N/AClass IIOngoingCinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit · Dr. Reddy's Laboratories, Inc. · 10584 bottlesClass IIOngoingCinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit · Dr. Reddy's Laboratories, Inc. · 35880 bottlesClass IIOngoingCinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable… · ACCORD HEALTHCARE, INC. · N/AClass IIOngoingCinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable… · ACCORD HEALTHCARE, INC. · N/AClass IIOngoing

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.