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Browse Drug Recalls

10 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 10 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 10 FDA drug recalls.

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DateProductReasonClassFirm
Apr 8, 2019 TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alpros... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOS... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML)... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYD... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOS... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadi... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding

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.