FDA Recall Ongoing 2026 recordClass II
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.
36,950
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,732
Class I recallsReasonable probability of serious health consequences24,263
Class II recallsTemporary or medically reversible health consequences2,873
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
2,071 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.
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A chart of recalls grouped by month.
Download CSVSummary (Year to date)
- 1,458 recalls have been announced year to date.
- Aug 2026 was 53% 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 | 24,263 |
| Class I | 9,732 |
| Class III | 2,873 |
| Not Yet Classified | 1 |
| Class | Recalls |
|---|---|
| Class II | 24,263 |
| Class I | 9,732 |
| Class III | 2,873 |
| Not Yet Classified | 1 |
FDA Recall Ongoing 2026 recordClass II
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
- Reason
- Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
- Reason
- Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.
- Reason
- Lack of Assurance of Sterility
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass III
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
- Reason
- Labeling: Missing Label
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
- Reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
- Reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall United States Terminated 2026 recordClass II
King Juice Company, Inc.
- Product
- Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UP…
- Reason
- Product contains undeclared Yellow No. 5.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall United States Terminated 2026 recordClass II
The Mochi Ice Cream Company, LLC
- Product
- My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 o…
- Reason
- Foreign object found inside retail container.
- Published
- May 6, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- Published
- April 29, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Published
- April 29, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Published
- April 29, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Published
- April 29, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass II
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Published
- April 29, 2026
- Distribution
- Nationwide
FDA Recall Ongoing 2026 recordClass III
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
- Published
- April 29, 2026
- 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.
