FDA Recall Terminated Historical recordClass II
Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.
- Reason
- Lack of sterility assurance.
- Published
- February 28, 2018
- Distribution
- Nationwide
Data Explorer
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to October 2026.
37,205
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,841
Class I recallsReasonable probability of serious health consequences24,366
Class II recallsTemporary or medically reversible health consequences2,892
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
2,073 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)
- 1,714 recalls have been announced year to date.
- Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
- The highest complete period was Jun 2026 (297).
- Oct 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 | 24,366 |
| Class I | 9,841 |
| Class III | 2,892 |
| Not Yet Classified | 2 |
| Class | Recalls |
|---|---|
| Class II | 24,366 |
| Class I | 9,841 |
| Class III | 2,892 |
| Not Yet Classified | 2 |
FDA Recall Terminated Historical recordClass II
Morphine 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
Midazolam HCl in 5% Dextrose 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
Midazolam 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
HYDROmorphone HCl Injection 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
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
Flexfrost
- Product
- Flexfrost Protein Ice Cream Vanilla Flexfrost L.L.C. 622 RT…
- Reason
- The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
- Published
- February 28, 2018
- Distribution
- Product was shipped to the following sta…
FDA Recall United States Terminated Historical recordClass II
Flexfrost
- Product
- Flexfrost Protein Ice Cream Mint Chip Flexfrost L.L.C. 622 R…
- Reason
- The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
- Published
- February 28, 2018
- Distribution
- Product was shipped to the following sta…
FDA Recall United States Terminated Historical recordClass II
Flexfrost
- Product
- Flexfrost Protein Ice Cream Coffee Flexfrost L.L.C. 622 RT 1…
- Reason
- The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
- Published
- February 28, 2018
- Distribution
- Product was shipped to the following sta…
FDA Recall United States Terminated Historical recordClass II
Flexfrost
- Product
- Flexfrost Protein Ice Cream Cinnamon Chai Flexfrost L.L.C. 6…
- Reason
- The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
- Published
- February 28, 2018
- Distribution
- Product was shipped to the following sta…
FDA Recall United States Terminated Historical recordClass II
Flexfrost
- Product
- Flexfrost Protein Ice Cream Chocolate Flexfrost L.L.C. 622 R…
- Reason
- The firm was notified by the Ohio Dept. of Agriculture (ODA) of insufficient pasteurization monitoring measures.
- Published
- February 28, 2018
- Distribution
- Product was shipped to the following sta…
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
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
- Reason
- Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
- Published
- February 21, 2018
- Distribution
- Product was distributed to SC, FL, NY, N…
FDA Recall Terminated Historical recordClass II
15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
- Reason
- Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
- Published
- February 21, 2018
- Distribution
- Product was distributed to SC, FL, NY, N…
FDA Recall Terminated Historical recordClass III
BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
- Reason
- CGMP Deviations: not manufactured according to current good manufacturing practices.
- Published
- February 21, 2018
- Distribution
- NY
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.
