FDA Recall Terminated Historical recordClass II
Epinephrine liquid 1:1000, RX, glass vial
- Reason
- Lack of sterility assurance.
- Published
- January 9, 2019
- Distribution
- Product was distributed exclusively in t…
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.
37,135
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,799
Class I recallsReasonable probability of serious health consequences24,349
Class II recallsTemporary or medically reversible health consequences2,891
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
Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gf-blends-recalls-truly-aip-all-purpose-flour-and-bread-mix-and-eat-gangster-flat-bread-pizza-mixPublished September 18, 2026
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.
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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 | 24,349 |
| Class I | 9,799 |
| Class III | 2,891 |
| Not Yet Classified | 1 |
| Class | Recalls |
|---|---|
| Class II | 24,349 |
| Class I | 9,799 |
| Class III | 2,891 |
| Not Yet Classified | 1 |
FDA Recall Terminated Historical recordClass II
Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
- Reason
- Lack of sterility assurance.
- Published
- January 9, 2019
- Distribution
- Product was distributed exclusively in t…
FDA Recall Terminated Historical recordClass II
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11.
- Reason
- Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
- Published
- January 9, 2019
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Tropical Lime/Lime Tropicale 5.…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
FDA Recall United States Terminated Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Sweet Kale/Chou Frise Doux: 5.5…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
FDA Recall United States Terminated Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Raspberry Acai/Framboises ET: 5…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
FDA Recall United States Terminated Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Avocado Ranch/Ranch et Avocats:…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
FDA Recall United States Terminated Historical recordClass I
Apio, Inc.
- Product
- Eat Smart Salad Shake Ups - Asian Sesame/Sesame Asiatique;…
- Reason
- Canadian Food Inspection Agency notified firm of positive finding Listeria Monocytogenes in several varieties of Eat Smart Single-Serve Salad Shake Ups.
- Published
- January 2, 2019
- Distribution
- Arizona, California, Colorado, Florida,…
FDA Recall United States Terminated Historical recordClass II
Root 23 LLC
- Product
- ROOT 23 CUCUMBER HABANERO SIMPLE SYRUP 375 ml
- Reason
- Non-compliance with process authority schedule; temperature at start of thermal process not recorded.
- Published
- January 2, 2019
- Distribution
- Distributed to the states of AZ, CA, CO,…
FDA Recall United States Terminated Historical recordClass I
Moonstruck Chocolate Company
- Product
- Sea Salt Caramels Tumbled In Milk Chocolate, Moonstruck bran…
- Reason
- The Sea Salt Caramels Tumbled In Milk Chocolate is recalled due to a potential to be contaminated with hazelnuts and the finished label does not declare hazelnuts.
- Published
- January 2, 2019
- Distribution
- distributed in AZ, CA, ID, NH, NY, OR, T…
FDA Recall Terminated Historical recordClass III
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)
- Reason
- Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
- Published
- December 26, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
- Reason
- Failed Dissolution Specifications.
- Published
- December 26, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4
- Reason
- Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
- Published
- December 26, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40
- Reason
- Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
- Published
- December 26, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
- Reason
- Failed Impurities/Degradation Specifications:Out of specification for impurities.
- Published
- December 26, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01
- Reason
- Superpotent Drug.
- Published
- December 26, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
- Reason
- Superpotent Drug: contains higher levels of Iron than labeled.
- Published
- December 26, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.
- Reason
- Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- Published
- December 26, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
- Reason
- Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- Published
- December 26, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
- Reason
- Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- Published
- December 26, 2018
- 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.
