FDA Recall United States Terminated Historical recordClass II
Aldi Inc
- Product
- Simply Nature Organic Green Lentils, 16 oz bag, UPC 04149829…
- Reason
- Product may contain undeclared wheat
- Published
- May 13, 2020
- 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.
37,115
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,793
Class I recallsReasonable probability of serious health consequences24,343
Class II recallsTemporary or medically reversible health consequences2,887
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/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessertPublished September 15, 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.
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 | 24,343 |
| Class I | 9,793 |
| Class III | 2,887 |
| Not Yet Classified | 1 |
| Class | Recalls |
|---|---|
| Class II | 24,343 |
| Class I | 9,793 |
| Class III | 2,887 |
| Not Yet Classified | 1 |
FDA Recall Terminated Historical recordClass I
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
- Reason
- Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
- Published
- May 6, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
- Reason
- Discoloration: product contains brown pellets
- Published
- May 6, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
- Reason
- CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
- Published
- May 6, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
- Reason
- Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
- Published
- April 29, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline. Inverness.Turssville, www.bracebygreatsmiles.com, i) Acceleration station, j) The Children's Therapy & Learning Center, www.childrenstlc.com. FLAVORED LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as a) Gregory P. Miller DDS FAGD, 1140 South Avenue North Mankato, MN 56003, www.gregmillerdds.com, b) Shelby, c) Carolina Custom Traders, Wake Forest, North Carolina, c) Palm Springs Dental Associates Jonathan W. Preble, DMD, 499 E. Central Parkway, Suite 200, Altamonte Springs, FL 32701, www.drjpreble.com. LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as Family Dental of Thronton, 12889 Quebec St, Thornton, CO 80602, www.FamilyDentalofThornton.com.
- Reason
- Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
- Published
- April 29, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
- Reason
- Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
- Published
- April 29, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
- Reason
- cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
- Published
- April 22, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144
- Reason
- Microbial contamination of non-sterile products: positive test for yeast and bacteria.
- Published
- April 22, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698
- Reason
- Microbial contamination of non-sterile products: positive test for yeast and bacteria.
- Published
- April 22, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- 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.
