FDA Recall Ongoing Historical recordClass III
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
- Reason
- Subpotent Drug
- Published
- September 10, 2025
- Distribution
- Nationwide
Data Explorer
Research historical outbreak investigations and the full recall archive, with charts, trends, and advanced filters. Looking for what's happening right now instead? See current Health Alerts.
Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.
37,059
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,786
Class I recallsReasonable probability of serious health consequences24,313
Class II recallsTemporary or medically reversible health consequences2,876
Class III recallsNot likely to cause adverse health consequencesQuick insights
A snapshot of the most notable patterns across all recorded FDA and USDA recalls.
Most recalled product100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
53 recalls
Most common hazardLack of Assurance of Sterility
2,072 recalls
Download matching recalls as CSV
CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.
Filters
Metric
View
A chart of recalls grouped by month.
Download CSVSummary (Year to date)
- 1,527 recalls have been announced year to date.
- Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
- The highest complete period was Jun 2026 (297).
- Sep 2026 is incomplete and not included in the figures above.
- Complete data
- Incomplete
A bar chart of the total number of recalls in this dataset by recall class.
| Class | Recalls |
|---|---|
| Class II | 24,313 |
| Class I | 9,786 |
| Class III | 2,876 |
| Not Yet Classified | 2 |
| Class | Recalls |
|---|---|
| Class II | 24,313 |
| Class I | 9,786 |
| Class III | 2,876 |
| Not Yet Classified | 2 |
FDA Recall Ongoing Historical recordClass II
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
- Reason
- Subpotent Drug
- Published
- September 10, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.
- Reason
- Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- Published
- September 3, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
- Reason
- Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- Published
- September 3, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
- Reason
- Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- Published
- September 3, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.
- Reason
- Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- Published
- September 3, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
- Reason
- Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- Published
- September 3, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
- Reason
- Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- Published
- September 3, 2025
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
- Reason
- Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
- Published
- September 3, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
- Reason
- CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Published
- September 3, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.
- Reason
- Discoloration
- Published
- September 3, 2025
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
Blue Bell Creameries, L.P.
- Product
- Chocolate Chip Cookie Dough ice cream cartons with a Moo-lle…
- Reason
- undeclared almond, walnut, and pecan.
- Published
- September 3, 2025
- Distribution
- AL, AR, FL, GA, IL, IN, KS, KY, LA, MO,…
FDA Recall Ongoing Historical recordClass II
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
- Reason
- Discoloration
- Published
- August 27, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
- Reason
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Published
- August 27, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass III
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
- Reason
- Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
- Published
- August 27, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass III
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
- Reason
- Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
- Published
- August 27, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
- Reason
- Lack of Assurance of Sterility.
- Published
- August 27, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
- Reason
- Lack of Assurance of Sterility.
- Published
- August 27, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)
- Reason
- Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
- Published
- August 20, 2025
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
- Published
- August 20, 2025
- Distribution
- Nationwide
Data last updated:
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions. Read the full medical disclaimer.
