Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 13, 2019 | Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectabl... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile singl... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 12, 2019 | 15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceutic... | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | Class II | MSM Nutraceuticals, LLC |
| Mar 12, 2019 | Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Aci... | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | Class II | MSM Nutraceuticals, LLC |
| Mar 12, 2019 | Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr... | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | Class II | MSM Nutraceuticals, LLC |
| Mar 12, 2019 | Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Aci... | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | Class II | MSM Nutraceuticals, LLC |
| Mar 11, 2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx ... | Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, there... | Class II | Iso-Tex Diagnostics, Inc |
| Mar 6, 2019 | Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx onl... | Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterilit... | Class II | Dr. Reddy's Laboratories, Inc. |
| Jan 29, 2019 | Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compoun... | Lack of assurance of sterility. | Class II | US Compounding Inc |
| Jan 24, 2019 | BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distr... | Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. | Class II | Sun Pharmaceutical Industries, Inc. |
| Jan 2, 2019 | Methocarbamol liquid 100mg/ml, RX, glass vial | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include inj... | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Glutathione liquid, 100mg/ml | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Cyclosporin liquid 0.05%, Rx, plastic dropper bottle | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... | Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. | Class II | Baxter Healthcare Corporation |
| Jan 2, 2019 | HCG liquid, 1000u/ml, RX, glass vial, various | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Cyclosporin liquid 0.2%, Rx, plastic dropper bottle | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Vitamin B12 liquid 1000mcg/ml, RX, glass vial | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Lidocaine gel 1%, RX, plastic dropper | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Epinephrine liquid 1:1000, RX, glass vial | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Cyclosporin liquid 0.5%, Rx, plastic dropper bottle | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Lidocaine gel 2%, RX, plastic dropper | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Glutathione liquid, 200mg/ml, Rx | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Testosteron Cypionate liquid 200mg/ml, RX, glass vial | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Cyclosporin liquid 1%, Rx, plastic dropper bottle | Lack of sterility assurance. | Class II | Hiers Enterprises, LLC dba Northwest Compoundin... |
| Jan 2, 2019 | Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, ... | Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle | Class II | Heritage Pharmaceuticals, Inc. |
| Dec 17, 2018 | IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide De... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Com... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Ph... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, ... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialist... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.0... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Com... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compou... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy C... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy C... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%,... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding ... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialis... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy C... | Lack of sterility assurance. | Class II | Promise Pharmacy, 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.