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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Ongoing Historical recordClass II

Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric Sulfate 1 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mcg/Chromium Picolinate 20 mcg/Pyridoxine HCL 2mg/ml), (10 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU + Vitamin A Acetate 100 IU/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy

by Tri-Coast Pharmacy

Reason: Lack of Assurance of Sterility
Recall initiated: November 17, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

View recall →

Data last updated: September 25, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.