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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

B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100 mg/Methylcobalamin 300 mcg/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

BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/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

Ascorbic Acid 500 mg/mL (50 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

Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/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

Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolinate 200 mcg/Glutamine (L) 30 mg/Lidocaine HCL 10 mg/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 Terminated Historical recordClass II

Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01

by Apotex Corp.

Reason: CGMP Deviations
Recall initiated: December 14, 2016
Reported by FDA: January 11, 2017
Distribution: United States

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Drug Recall Terminated Historical recordClass II

Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01

by Apotex Corp.

Reason: CGMP Deviations
Recall initiated: December 14, 2016
Reported by FDA: January 11, 2017
Distribution: United States

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Drug Recall Terminated Historical recordClass II

Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04

by Gentell, Inc

Reason: CGMP Deviations
Recall initiated: December 15, 2016
Reported by FDA: January 11, 2017
Distribution: United States

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Drug Recall Terminated Historical recordClass II

Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007

by Gentell, Inc

Reason: CGMP Deviations
Recall initiated: December 15, 2016
Reported by FDA: January 11, 2017
Distribution: United States

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Drug Recall Terminated Historical recordClass II

Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala FL

by Wells Pharmacy Network LLC

Reason: Lack of Assurance of Sterility
Recall initiated: September 21, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

by Wells Pharmacy Network LLC

Reason: Lack of Assurance of Sterility
Recall initiated: September 21, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

by Wells Pharmacy Network LLC

Reason: Lack of Assurance of Sterility
Recall initiated: September 21, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug 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

by Wells Pharmacy Network LLC

Reason: Lack of Assurance of Sterility
Recall initiated: September 21, 2016
Reported by FDA: January 11, 2017
Distribution: Nationwide

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Drug 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

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

TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/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

Testosterone Propionate 100 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

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

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 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

by VIRTUS PHARMACEUTICALS OPCO II L

Reason: cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Recall initiated: December 12, 2016
Reported by FDA: January 4, 2017
Distribution: Nationwide

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Drug 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

by VIRTUS PHARMACEUTICALS OPCO II L

Reason: cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Recall initiated: December 12, 2016
Reported by FDA: January 4, 2017
Distribution: Nationwide

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Drug 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

by VIRTUS PHARMACEUTICALS OPCO II L

Reason: cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Recall initiated: December 12, 2016
Reported by FDA: January 4, 2017
Distribution: Nationwide

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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.