FDA Recall Terminated Historical recordClass II
HYDROmorphone HCl Injection in all strengths, all doses, and all packaging.
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.
37,118
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/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
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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 | 24,343 |
| 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 II
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.
- Reason
- Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
- Published
- February 28, 2018
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
Aryzta North America
- Product
- Italian White Bread Dough Sticks
- Reason
- Aryzta LLC is recalling multiple lots of bread dough following a supplier's recall of a yeast ingredient due to potential contamination with metal fragments.
- Published
- February 28, 2018
- Distribution
- Subway distribution warehouses in Florid…
FDA Recall United States Terminated Historical recordClass II
Aryzta North America
- Product
- Italian White Bread Dough Sticks
- Reason
- Aryzta LLC is recalling multiple lots of bread dough following a supplier's recall of a yeast ingredient due to potential contamination with metal fragments.
- Published
- February 28, 2018
- Distribution
- Subway distribution warehouses in Florid…
FDA Recall Terminated Historical recordClass II
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
- Reason
- CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
- Reason
- Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
- Reason
- Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile swabs. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9010 UPC 6 18029 79139 9
- Reason
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Skin antisepsis and oral cleansing. Contains Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9009 UPC 6 18029 79140 5
- Reason
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974-S UPC 6 18029 83097 5
- Reason
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6974 UPC 6 18029 83097 5
- Reason
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6964 UPC 6 18029 83075 3
- Reason
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3
- Reason
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6922-B UPC 6 18029 83032 6
- Reason
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Published
- February 21, 2018
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6922 UPC 6 18029 83032 6
- Reason
- Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
- Published
- February 21, 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.
