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Browse Drug Recalls

12 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 12 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 12 FDA drug recalls.

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DateProductReasonClassFirm
May 15, 2015 Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, comp... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx onl... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded b... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, d... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only,... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx onl... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, comp... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx onl... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, comp... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, c... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial,... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispense... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.