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Browse Drug Recalls

11 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 11 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 11 FDA drug recalls.

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DateProductReasonClassFirm
Jul 22, 2019 Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise P... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake we... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate,... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compo... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Inj... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL V... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded b... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL V... Lack of Processing Controls Class II Wise 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.