How many drug recalls are there each month?
The FDA classified 24 drug recalls in August 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 Aug 2026, is 24.
- That is down 29% 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 September 16, 2026. The source's own words are in quotes.
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Class I (most serious)
Baxter Healthcare Corporation (Deerfield, IL): Dextrose Injection, USP
Particles or foreign matter. “Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.”
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Class III (least serious)
Ajanta Pharma USA Inc (Bridgewater, NJ): Fluphenazine Hydrochloride Tablets, USP
Impurities or contamination. “Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.”
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Class III (least serious)
ImprimisRx NJ LLC (Ledgewood, NJ): Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution
Too strong or too weak. “Subpotent Drug”
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Not yet classified
OurPharma LLC (Fayetteville, AR): fentaNYL Citrate
Mix-ups and label errors. “Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).”
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Class I (most serious)
Baxter Healthcare Corporation (Deerfield, IL): 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case
Particles or foreign matter. “Presence of particulate matter: Particulates identified as fiberglass”
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Class I (most serious)
OPTIMAL BALANCE PHARMACY (Houston, TX): Glutathione 200 mg/mL
Can't be shown to be sterile. “Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.”
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Class II
Allies Group Inc. (Wilmington, DE): THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%) (4 products)
Too strong or too weak. “Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.”
-
Class II
Baxter Healthcare Corporation (Deerfield, IL): Nexterone (amiodarone HCI) (17 products)
Not made under good manufacturing practices. “CGMP Deviations”
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Class II
Golden State Medical Supply Inc. (Camarillo, CA): Prasugrel HCI, Tablets, USP
Doesn't dissolve as it should. “Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution”
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Class II
Lexia LLC (Franklin, TN): Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%) (2 products)
Not made under good manufacturing practices. “CGMP Deviations: Potential contamination of raw material”
-
Class II
Mylan Pharmaceuticals Inc (Morgantown, WV): Prasugrel Tablets, USP
Doesn't dissolve as it should. “Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria”
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Class II
Mylan Pharmaceuticals Inc (Morgantown, WV): Carton label
Doesn't dissolve as it should. “Failed Dissolution Specifications”
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Class II
Sage Products, LLC (Cary, IL): 2% Chlorhexidine Gluconate* Cloth, Non-sterile
Impurities or contamination. “Cross Contamination with Other Products”
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Class II
Teva Pharmaceuticals USA, Inc (Parsippany, NJ): traZODone Hydrochloride Tablets, USP
Particles or foreign matter. “Presence of Foreign Tablets/Capsules”
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Class III (least serious)
American Health Packaging (Columbus, OH): Buprenorphine Sublingual Tablets (C-III)
Mix-ups and label errors. “Labeling: Label Mix-up”
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Class III (least serious)
Bionpharma Inc. (Princeton, NJ): Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Particles or foreign matter. “Presence of Foreign Tablets/Capsules”
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Class III (least serious)
Chiesi USA, Inc. (Cary, NC): Revcovi (elapegademase-lvlr) Injection
Failed stability or other quality checks. “Failed Stability Specifications: Out of specification stability result for the protein concentration profile.”
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Class III (least serious)
Supernus Pharmaceuticals, Inc. (Rockville, MD): Trokendi XR, (topiramate) extended-release capsules
Doesn't dissolve as it should. “Failed dissolution specifications.”
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Class I (most serious)
B BRAUN MEDICAL INC (Allentown, PA): Lactated Ringer's Injection USP
Particles or foreign matter. “Presence of Particulate matter.”
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Class I (most serious)
Fresenius Kabi USA, LLC (Lake Zurich, IL): Tyenne (tocilizumab-aazg) Injection
Particles or foreign matter. “Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.”
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 September 16, 2026). https://chart.ly/charts/drug-recalls-by-month (accessed October 18, 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 |
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