Browse Drug Recalls
14,396 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,396 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 14,396 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 20, 2016 | Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, ... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syri... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 20, 2016 | Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by... | Lack of Assurance of Sterility | Class II | Pharmakon Pharmaceuticals, Inc. |
| Apr 18, 2016 | Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV U... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | 0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONL... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR I... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medica... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Med... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medic... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Piperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist ... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist He... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | 1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist ... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical ... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | 70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Bapti... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist He... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist ... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Hea... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Tow... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Heal... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-... | Defective Container: Excess lidding material accumulation between the seal and the cup resulting ... | Class II | VistaPharm, Inc. |
| Apr 18, 2016 | Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist H... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist He... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medi... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANE... | Lack of Sterility Assurance | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 18, 2016 | Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... | Lack of Sterility Assurance. | Class II | Baptist Health Medical Towers Pharmacy and Infu... |
| Apr 12, 2016 | Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium... | Discoloration: presence of atypical yellow discoloration of the solution . | Class II | Baxter Healthcare Corp. |
| Apr 7, 2016 | Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 ... | Presence of Particulate Matter | Class II | Akorn, Inc. |
| Apr 5, 2016 | Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intraven... | Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Pres... | Class II | Fresenius Kabi USA, LLC |
| Apr 4, 2016 | BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. ... | Microbial Contamination of Non-Sterile Products: Failed S.aureus test. | Class II | Keystone Laboratories Inc |
| Mar 31, 2016 | LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufacture... | Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033 | Class II | Invisiblu International LLC |
| Mar 30, 2016 | Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr... | Failed Impurities/Degradation Specifications; 12 month stability time point | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 25, 2016 | All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE... | Lack of Processing Controls | Class II | Reliable Rexall-A Compounding Pharmacy |
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.