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Browse Drug Recalls

25 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 25 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 25 FDA drug recalls.

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DateProductReasonClassFirm
Jun 15, 2015 Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Com... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Co... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Comp... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Cent... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vi... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound C... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vial... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liber... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, L... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Comp... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial,... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Com... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Dr... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug C... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Li... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Cent... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Lib... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical

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.