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Browse Drug Recalls

15 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 15 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 15 FDA drug recalls.

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DateProductReasonClassFirm
Jul 25, 2018 Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laborator... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) I... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier'... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laborat... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laborator... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Labor... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory

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.