FDA Recall United States Terminated Historical recordClass II
Secrets Of The Tribe
- Product
- Amla Alcohol-Free Extract, 2 oz. glass bottle, UPC 041979376…
- Reason
- Product has elevated level of lead.
- Published
- November 2, 2022
- 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.
37,066
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
Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 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 | 24,313 |
| 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
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Published
- October 26, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
- Reason
- Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
- Published
- October 26, 2022
- Distribution
- Nationwide
FDA Recall Completed Historical recordClass II
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.
- Reason
- Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
- Published
- October 26, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 26, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 26, 2022
- Distribution
- Nationwide
FDA Recall Completed Historical recordClass II
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
- Reason
- Out of specification for related substances (impurities).
- Published
- October 26, 2022
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
Nestle-USA, Inc. (Corporate Office)
- Product
- "***Nestle***STUFFED***CHOCOLATE CHIP COOKIE DOUGH***4 JUMBO…
- Reason
- Consumer complaints reported presence of white pieces of plastic in cookie product.
- Published
- October 26, 2022
- Distribution
- AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL,…
FDA Recall United States Terminated Historical recordClass II
D. F. Stauffer Biscuit Co, Inc.
- Product
- White frosted animal cookies with multi-colored non-pareils…
- Reason
- Potential contamination with foreign material (metal).
- Published
- October 26, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8
- Reason
- Marketed Without An Approved NDA/ANDA; Unapproved new drug
- Published
- October 19, 2022
- Distribution
- United States including Puerto Rico and…
FDA Recall Terminated Historical recordClass II
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1
- Reason
- Marketed Without An Approved NDA/ANDA; Unapproved new drug
- Published
- October 19, 2022
- Distribution
- United States including Puerto Rico and…
FDA Recall United States Terminated Historical recordClass II
Eden Foods, Inc
- Product
- Eden Organic Apple Juice in 32floz., 64floz., and 1.82L size…
- Reason
- culling not performed to remove rotted apples, excessive levels of patulin found in 1 lot
- Published
- October 19, 2022
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass III
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
- Reason
- Presence of Particulate Matter: Piece of metal found in a vial
- Published
- October 12, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
- Reason
- Lack of Assurance of Sterility: environmental monitoring failure.
- Published
- October 12, 2022
- Distribution
- Nationwide
FDA Recall Completed Historical recordClass III
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
- Reason
- Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
- Published
- October 12, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)
- Reason
- Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
- Published
- October 12, 2022
- Distribution
- Distributed in the United States and Pue…
FDA Recall Terminated Historical recordClass III
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
- Reason
- Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
- Published
- October 5, 2022
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 5, 2022
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 5, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
- Reason
- Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
- Published
- October 5, 2022
- 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.
