Browse Drug Recalls
6,348 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,348 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 6,348 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 2, 2015 | 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxt... | Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint ... | Class II | Baxter Healthcare Corp. |
| 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 |
| 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 | 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 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 | 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 | 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-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 | 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-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-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 | 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-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 | 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 | 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 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 | 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-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-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-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-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 | 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 | 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-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 | 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 | 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 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-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-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 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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/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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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, 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 | 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 | 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 | 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 |
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.