FDA Recall Terminated Historical recordClass II
Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.
37,139
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,799
Class I recallsReasonable probability of serious health consequences24,349
Class II recallsTemporary or medically reversible health consequences2,891
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/deanos-pasta-issue-allergy-alert-undeclared-lobster-pear-and-pecorino-triangoli-ravioliPublished September 24, 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 | 24,349 |
| Class I | 9,799 |
| Class III | 2,891 |
| Not Yet Classified | 1 |
| Class | Recalls |
|---|---|
| Class II | 24,349 |
| Class I | 9,799 |
| Class III | 2,891 |
| Not Yet Classified | 1 |
FDA Recall Terminated Historical recordClass II
Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30
- Reason
- cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Published
- January 4, 2017
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30
- Reason
- cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Published
- January 4, 2017
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30
- Reason
- cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Published
- January 4, 2017
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90
- Reason
- cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Published
- January 4, 2017
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
- Published
- January 4, 2017
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
Bio-Botanica, Inc.
- Product
- Liquid VITAMIN D-3 Drops distributed under the following pri…
- Reason
- The lots exceed the label claim for Vitamin D3 of 2000 IU per drop.
- Published
- January 4, 2017
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass I
Cargill Cocoa & Chocolate, Inc.
- Product
- Wilbur; IM10021; B558 Semisweet Chocolate Drops, 2000 CT; Ne…
- Reason
- Cargill Cocoa & Chocolate is recalling 50 lb. cartons of Wilbur B558 Semi-Sweet Chocolate Drops because it may contain undeclared milk.
- Published
- January 4, 2017
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
- Reason
- CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
- Published
- December 28, 2016
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
- Reason
- Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
- Published
- December 28, 2016
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass I
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
- Reason
- Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
- Published
- December 28, 2016
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
- Reason
- Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- Published
- December 28, 2016
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
- Reason
- Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- Published
- December 28, 2016
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
- Reason
- CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
- Published
- December 28, 2016
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
- Reason
- Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
- Published
- December 28, 2016
- 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.
