Browse Drug Recalls

1,710 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,710 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 1,710 FDA drug recalls, Class III.

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DateProductReasonClassFirm
Jul 18, 2013 ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, ... Microbial Contamination of Non-Sterile Products: This product is being recalled because a stabili... Class III Vi-Jon, Inc.
Jul 18, 2013 TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 C... Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable... Class III GlaxoSmithKline, LLC.
Jul 15, 2013 Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02 Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulti... Class III Braintree Laboratories Inc.
Jun 28, 2013 Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (impri... Subpotent; Beta carotene (Vitamin A) Class III Stayma Consulting Service, LLC.
Jun 28, 2013 NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (N... Subpotent; Beta carotene (Vitamin A) Class III Stayma Consulting Service, LLC.
Jun 28, 2013 Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imp... Subpotent; Beta carotene (Vitamin A) Class III Stayma Consulting Service, LLC.
Jun 28, 2013 Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprin... Subpotent; Beta carotene (Vitamin A) Class III Stayma Consulting Service, LLC.
Jun 28, 2013 Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprin... Subpotent; Beta carotene (Vitamin A) Class III Stayma Consulting Service, LLC.
Jun 28, 2013 Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blis... Subpotent; Beta carotene (Vitamin A) Class III Stayma Consulting Service, LLC.
Jun 28, 2013 Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imp... Subpotent; Beta carotene (Vitamin A) Class III Stayma Consulting Service, 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 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 Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-41... Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin... Class III Teva Pharmaceuticals USA, 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 3, 2013 Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54),... Failed Impurities/Degradation Specifications Class III Actavis
May 31, 2013 Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.... Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxy... Class III Pfizer Inc.
May 31, 2013 Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.... Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogen... Class III Pfizer Inc.
May 31, 2013 Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... Failed Dissolution Specification Class III Pfizer Inc
May 30, 2013 Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injectio... Presence of Particulate Matter; particulate found in retain samples Class III Pharmalucence, Inc.
May 28, 2013 Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sul... Failed Stability Specifications: Unable to meet shelf life expiry. Class III Faria Limited LLC dba Sheffield Pharmaceuticals
May 21, 2013 Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dos... Failed Impurities/Degradation Specification Class III Fresenius Kabi USA, LLC
May 15, 2013 Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorph... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 cap... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing Class III Novartis Consumer Health
May 15, 2013 Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextrometho... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing Class III Novartis Consumer Health
May 15, 2013 Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit... Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 15, 2013 Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorph... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlor... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorphen... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 13, 2013 Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use... Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpu... Class III West-ward Pharmaceutical Corp.

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.