Browse Drug Recalls
2,029 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,029 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 2,029 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jun 21, 2013 | I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcoh... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 18, 2013 | NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydr... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan ... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydr... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HB... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextro... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and ph... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, ... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 17, 2013 | ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distribu... | Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 ... | Class I | Advance Pharmaceutical Inc |
| Jun 14, 2013 | Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablet... | Labeling: Missing Label; missing label on blister card | Class III | Boehringer Ingelheim Roxane Inc |
| Jun 13, 2013 | Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingre... | Failed Stability Specifications: Out of specification results for particle size were obtained at ... | Class III | Bayer HealthCare Pharmaceuticals Inc. |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| Jun 11, 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Gra... | Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. | Class II | Church & Dwight Inc |
| May 23, 2013 | INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 m... | Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is... | Class II | Indelicare LLC |
| May 3, 2013 | Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Excl... | Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredi... | Class II | Kareway Product Inc |
| May 1, 2013 | CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed ... | cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled in... | Class II | Medicis Pharmaceutical Corp |
| Apr 22, 2013 | Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-0... | Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was f... | Class II | Mylan Pharmaceuticals Inc. |
| Apr 22, 2013 | Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufact... | Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine ... | Class II | Legacy Pharmaceutical Packaging LLC |
| Apr 19, 2013 | Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tub... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
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.