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Browse Drug Recalls

31 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 31 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 31 FDA drug recalls.

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DateProductReasonClassFirm
Sep 12, 2016 Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, ... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II The Apothecary Shoppe LLC
Sep 12, 2016 Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL)... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II The Apothecary Shoppe LLC
Sep 12, 2016 Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials... Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compound... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shop... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Com... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compoun... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe,... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Com... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Comp... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compo... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Sh... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shopp... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compoun... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Com... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Sho... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compou... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC
Jun 26, 2015 SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apo... Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring d... Class II The Apothecary Shoppe LLC

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.