Browse Drug Recalls
2,002 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,002 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 2,002 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 2, 2013 | GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, Over The Counter, Distribu... | Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg may be potentially misla... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CapsuleTOPRIL, Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 12.5 mg may have potentially been mislabeled as the... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | TEMAZEPAM, Capsule, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: TEMAZEPAM, Capsule, 7.5 mg may have potentially been mislabeled as one of ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, Rx only, Distributed by: Aida... | Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been m... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | TRIFLUOPERAZINE HCL, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PIOGLITAZONE, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, N... | Labeling: Label Mixup: PIOGLITAZONE, Tablet, 15 mg may have potentially been mislabeled as one of... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NIACIN TR, Tablet, 750 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling: Label Mixup: NIACIN TR, Tablet, 750 mg may have potentially been mislabeled as the foll... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | PSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Ser... | Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as RE... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ASCORBIC ACID, Tablet, 250 mg, Over The Counter, Distributed by: AidaPak Serv... | Labeling: Label Mixup: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MYCOPHENOLATE MOFETIL, Capsule, 250 mg, Rx only, Distributed by: AidaPak Serv... | Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as t... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | RILUZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 0... | Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the follow... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC... | Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROP... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, L... | Labeling:Label Mixup; VERAPAMIL HCL ER, Tablet, 240 mg may be potentially mislabeled as TRIFLU... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VITAMIN B COMPLEX W/C, Tablet, 0 mg, Over The Counter, Distributed by: AidaPa... | Labeling: Label Mixup: VITAMIN B COMPLEX W/C, Tablet, 0 mg may have potentially been mislabeled a... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ACARBOSE, Tablet 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23... | Labeling: Label Mixup; ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS G... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | NIACIN TR, Tablet, 1000 mg, Rx only, Distributed by: AidaPak Service, LLC, ND... | Labeling: Label Mixup: NIACIN TR, Tablet, 1000 mg may have potentially been mislabeled as the fol... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak ... | Labeling: Label Mixup: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been misla... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by... | Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mi... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The... | Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be p... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Se... | Labeling: Label Mixup: POTASSIUM ACID PHOSPHATE, Tablet, 500 mg may have potentially been mislabe... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CALCITRIOL, Capsule, 0.25 mcg, Rx only, Distributed by: AidaPak Service, LLC,... | Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following d... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | ASCORBIC ACID, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Serv... | Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC... | Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | VENLAFAXINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LL... | Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 100 mg may have potentially was mislabeled as tiZ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaP... | Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | SELENIUM, Tablet, 50 mcg, Over The Counter, Distributed by: AidaPak Service, ... | Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the follo... | Class II | Aidapak Services, LLC |
| Jul 2, 2013 | MERCapsuleTOPURINE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, ... | Labeling: Label Mixup: MERCapsuleTOPURINE, Tablet, 50 mg may have potentially been mislabeled as ... | Class II | Aidapak Services, LLC |
| Jul 1, 2013 | Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose ... | Presence of particulate matter: characterized as thin colorless flakes that are visually and che... | Class II | Fresenius Kabi USA, LLC |
| Jun 27, 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... | Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... | Class III | Max Huber Research Labs, Inc. |
| Jun 27, 2013 | Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 1... | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | Fabscout Entertainment, Inc |
| Jun 27, 2013 | Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | Fabscout Entertainment, Inc |
| Jun 27, 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... | Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... | Class III | Max Huber Research Labs, Inc. |
| Jun 27, 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, ... | Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunsc... | Class III | Max Huber Research Labs, Inc. |
| Jun 21, 2013 | FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I LOVE BACON Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl o... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol, Net Wt. ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Aceta... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol, Net Wt. 1 fl ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I love to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 f... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Share a Smile Mixed berry Anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl o... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands 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.