FDA Recall Terminated Historical recordClass II
Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
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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
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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 I
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
- Reason
- Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31
- Reason
- Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
- Reason
- Failed Stability Specifications: Out of specification for viscosity.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz. (474 mL), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16.
- Reason
- Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
- Published
- June 19, 2019
- Distribution
- Puerto Rico
FDA Recall Terminated Historical recordClass III
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.
- Reason
- Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
- Reason
- Failed Dissolution Specifications: Out of specification result for dissolution.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
- Reason
- Failed Dissolution Specifications: Out of specification result for dissolution.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
- Reason
- Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason
- Lack of Sterility Assurance.
- Published
- June 19, 2019
- 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.
