Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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DateProductReasonClassFirm
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 Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial,... Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of a... Class II Hospira 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 25, 2013 Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx o... Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), there... Class II Apotex Inc
Jun 24, 2013 Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM ... Subpotent Drug; 15-month stability test station Class II Fresenius Kabi USA, LLC
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 MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, ... Presence of Precipitate; potential for incomplete constitution upon addition of diluent. Class II AstraZeneca Pharmaceuticals LP
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 Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37... Presence of foreign substance: One lot of the product may contain black foreign particles Class II Bracco Diagnostics 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 Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, ... Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets. Class II Sandoz Incorporated
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 20, 2013 AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infu... Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bact... Class II Gilead Sciences, Inc.
Jun 19, 2013 AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial,... Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on cert... Class II Astellas Pharma US 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 Severe Cold & Cough powder packets containing Daytime formula (aceta... Presence of Foreign Substance: The products are being recalled because they may contain foreign s... Class II Novartis Consumer Health
Jun 18, 2013 Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diph... Presence of Foreign Substance: The products are being recalled because they may contain foreign s... Class II Novartis Consumer Health
Jun 18, 2013 Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 m... 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 Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hy... 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 NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine... Presence of Foreign Substance: The products are being recalled because they may contain foreign s... Class II Novartis Consumer Health
Jun 18, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... Class II Teva Pharmaceuticals USA, Inc.
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 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 coun... Failed Dissolution Specifications: Product is being recalled due to out of specification dissolut... Class II Teva Pharmaceuticals USA, 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.