Browse Drug Recalls
1,723 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,723 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 1,723 FDA drug recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 16, 2020 | Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement ... | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tada... | Class I | Y-O Management LLC, dba Natural Remedy Store |
| Feb 7, 2020 | Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only... | Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may ... | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Dec 27, 2019 | Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repacka... | Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer... | Class I | RemedyRepack Inc. |
| Dec 20, 2019 | Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro P... | Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Dec 17, 2019 | Panther Platinum 30000 Capsules, in green, black background with white, red t... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background wi... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Stallion Platinum 30000 Capsules in blue,orange,white background with red,whi... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,whi... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose ... | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Class I | Hikma Pharmaceuticals USA Inc. |
| Dec 6, 2019 | Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, D... | Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total ... | Class I | Lannett Company, Inc. |
| Nov 20, 2019 | Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by... | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... | Class I | AuroMedics Pharma LLC |
| Nov 20, 2019 | Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by:... | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... | Class I | AuroMedics Pharma LLC |
| Nov 13, 2019 | Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 ma... | Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil. | Class I | Natures Rx |
| Nov 8, 2019 | Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Te... | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovere... | Class I | Med Man Distribution, Inc. |
| Nov 8, 2019 | UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) ... | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovere... | Class I | Med Man Distribution, Inc. |
| Oct 25, 2019 | 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira... | Presence of Particulate Matter. | Class I | ICU Medical Inc |
| Oct 25, 2019 | LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira... | Presence of Particulate Matter. | Class I | ICU Medical Inc |
| Oct 22, 2019 | Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 c... | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tada... | Class I | Green Lumber Holdings, LLC |
| Sep 16, 2019 | Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2... | Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. | Class I | FITOTERAPIA USA, INC |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, ... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartri... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartri... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartr... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 6, 2019 | Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g N... | Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified a... | Class I | Darmerica, LLC |
| Aug 30, 2019 | Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit ... | Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerob... | Class I | Plastikon Healthcare LLC |
| Jul 9, 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... | Failed dissolution specifications : failed results at the 3-month stability time point. | Class I | Jubilant Cadista Pharmaceuticals, Inc. |
| Jun 28, 2019 | Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 ... | Presence of Particulate Matter; glass particulates | Class I | Fresenius Kabi USA, LLC |
| Jun 7, 2019 | Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syri... | Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the... | Class I | PharMEDium Services, LLC |
| May 28, 2019 | Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredient... | Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage informat... | Class I | Novis PR, Inc. |
| May 21, 2019 | PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx On... | Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... | Class I | Heritage Pharmaceuticals, Inc. |
| May 21, 2019 | AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only,... | Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... | Class I | Heritage Pharmaceuticals, Inc. |
| May 11, 2019 | Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by:... | Cross Contamination with Other Products: product is being recalled due to possible cross-contamin... | Class I | Novartis Pharmaceuticals Corp. |
| May 6, 2019 | The Beast, The Beast can be taken under the situation of Heart disease and ev... | Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discove... | Class I | Stiff Boy LLC |
| Apr 30, 2019 | Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Onl... | Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product | Class I | Par Pharmaceutical, Inc. |
| Apr 23, 2019 | Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display box... | Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil. | Class I | D.B.P. Distribution |
| Apr 19, 2019 | FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx... | Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 ... | Class I | Alvogen, Inc |
| Apr 9, 2019 | Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister... | Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sild... | Class I | SELECT DISTRIBUTIONS LLC |
| Apr 5, 2019 | Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufa... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undecla... | Class I | Brian P. Richardson |
| Mar 28, 2019 | Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, M... | Presence of Particulate Matter: One vial was found to contain a hair. | Class I | Aurobindo Pharma USA Inc. |
| Mar 15, 2019 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL)... | Presence of Particulate Matter; glass particulates | Class I | Pfizer Inc. |
| Mar 14, 2019 | Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingr... | Class I | Ata International Inc |
| Mar 5, 2019 | LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containi... | Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approve... | Class I | USA LESS Inc. |
| Feb 22, 2019 | Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per pac... | Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutrami... | Class I | Golean Detox US |
| Feb 13, 2019 | Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gr... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Class I | Todd Holiday dba Sunstone Organics |
| Feb 13, 2019 | Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Class I | Todd Holiday dba Sunstone Organics |
| Feb 13, 2019 | White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 ... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Class I | Todd Holiday dba Sunstone Organics |
| Feb 13, 2019 | White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) ... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Class I | Todd Holiday dba Sunstone Organics |
| Feb 1, 2019 | Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx... | Presence of Particulate Matter: particulate matter identified as copper salts | Class I | Mylan Institutional Inc |
| Jan 25, 2019 | the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pru... | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... | Class I | Natures Rx |
| Jan 8, 2019 | 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Hap... | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... | Class I | Happy Together, Inc. |
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.