How many drug recalls are there each month?
The FDA classified 38 drug recalls in September 2026. Since January 2025, the monthly count has ranged from 17 in February 2026 to 44 in July 2026. Each recall counts once however many products, strengths or lots it covers, in the month of the weekly Enforcement Report where FDA first listed it, often weeks after the company announced it, so months with five weekly reports tend to count more. The month in progress is left off the chart; its newest recalls are listed below it, each with FDA's reason.
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Key facts
Measure: Drug recalls. Written from the data below.
- The latest figure, for Sep 2026, is 38.
- That is up 12% from 34 in Jan 2025.
- The highest was 44 in Jul 2026.
- The lowest was 17 in Feb 2026.
The newest drug recalls
Newest first, as of October 28, 2026. The source's own words are in quotes.
-
Class I (most serious)
Greenwich Rx (Tomball, TX): Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water)
Can't be shown to be sterile. “Microbial Contamination of Sterile Products”
-
Class I (most serious)
Par Health USA, LLC (Rochester, MI): Argatroban Injection, USP (2 products)
Particles or foreign matter. “Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.”
-
Class II
Ascend Laboratories, LLC (Bedminster, NJ): Amlodipine and Olmesartan Medoxomil Tablets
Doesn't dissolve as it should. “Out of specification due to dissolution.”
-
Class II
AvKARE (Pulaski, TN): Amitriptyline Hydrochloride, Tablets, USP
Doesn't dissolve as it should. “Failed dissolution specifications.”
-
Class II
Hikma Pharmaceuticals USA INC. (Columbus, OH): Abirtega (abiraterone acetate) USP
Failed stability or other quality checks. “Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.”
-
Class II
Pfizer (Manhattan, NY): Levoxyl (levothyroxine sodium tablets, USP), tablets (2 products)
Too strong or too weak. “Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.”
-
Class II
PRITAM INTERNATIONAL PRIVATE LIMITED (Haridwar, India): Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride... (17 products)
Not made under good manufacturing practices. “CGMP Deviations.”
-
Class II
Right Value Drug Stores LLC (Irving, TX): Testosterone Cypionate
Can't be shown to be sterile. “Lack of sterility assurance.”
-
Class II
Shenzhen Techdow Pharmaceutical Co., Ltd. (Shenzhen, China): Heparin Sodium Injection, USP
Can't be shown to be sterile. “Lack of Assurance of Sterility”
-
Class II
STRIDES PHARMA INC (Bridgewater, NJ): Cinacalcet Tablets
Doesn't dissolve as it should. “Failed dissolution specifications”
-
Class III (least serious)
Viatris, Inc. (Morgantown, WV): Telmisartan and Amlodipine, Tablets, USP
Too strong or too weak. “Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications”
-
Class II
American Health Packaging (Columbus, OH): Metoclopramide Tablets, USP
Particles or foreign matter. “Presence of Foreign Tablets/Capsules”
-
Class II
Houston Rx LLC (Houston, TX): Sermorelin (2 products)
“Lack of process control”
-
Class II
Teva Pharmaceuticals USA, Inc (Parsippany, NJ): Metoclopramide Tablets, USP
Particles or foreign matter. “Presence of Foreign Tablets/Capsules”
-
Class II
Zydus Pharmaceuticals (USA) Inc (Pennington, NJ): Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial
Impurities or contamination. “Failed Impurities/Degradation Specifications.”
-
Class II
Apothecary Pharma LLC (Cary, NC): Apothecary NAD+ Injection 200 mg/mL (2 products)
Can't be shown to be sterile. “Lack of Assurance of Sterility”
-
Class II
BioSpectra, Inc. (Bangor, PA): Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
Failed stability or other quality checks. “Failed stability specifications”
-
Class II
Carolina Infusion, LLC (Ridgeland, SC): Tri-MIX (PAPAV/PHENTO/ALPROS) (16 products)
Can't be shown to be sterile. “Lack of Assurance of Sterility: Related to processing equipment used in compounded product.”
-
Class II
Cipla USA, Inc. (Warren, NJ): Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin)
Impurities or contamination. “Failed Impurities/Degradation Specifications”
-
Class II
J&J INNOVATIVE MEDICINE (Malvern, PA): IMAAVY (nipocalimab-aahu) Injection
Particles or foreign matter. “Presence of particulate matter.”
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Source and date
- Data as of
- Published
Citation
Chartly. “How many drug recalls are there each month?” Chart. Data: U.S. Food and Drug Administration, Enforcement Reports (openFDA drug recall data), https://open.fda.gov/apis/drug/enforcement/ (data as of October 28, 2026). https://chart.ly/charts/drug-recalls-by-month (accessed November 7, 2026).
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The data
Download data (CSV)The file has the numbers in this table, with the source, license and date. Please credit the source and Chartly. Developers can also get them as JSON (how).
| Month FDA classified the recall | Drug recalls |
|---|---|
| Jan 2025 | 34 |
| Feb 2025 | 19 |
| Mar 2025 | 27 |
| Apr 2025 | 35 |
| May 2025 | 21 |
| Jun 2025 | 20 |
| Jul 2025 | 29 |
| Aug 2025 | 27 |
| Sep 2025 | 30 |
| Oct 2025 | 37 |
| Nov 2025 | 24 |
| Dec 2025 | 24 |
| Jan 2026 | 21 |
| Feb 2026 | 17 |
| Mar 2026 | 24 |
| Apr 2026 | 37 |
| May 2026 | 33 |
| Jun 2026 | 28 |
| Jul 2026 | 44 |
| Aug 2026 | 24 |
| Sep 2026 | 38 |
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