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Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

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DateProductReasonClassFirm
Jul 17, 2015 lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume i... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only,... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, P... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, F... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syr... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Prese... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-... Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it... Class III Sun Pharma Global Fze
Jul 17, 2015 morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a sy... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, P... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syring... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syri... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a s... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags,... Presence of Particulate Matter: Customer complaint for an insect found free floating inside a sin... Class I Baxter Healthcare Corp.
Jul 17, 2015 HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Prese... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 16, 2015 Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutua... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmac... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmac... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg ... Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml inst... Class II Safecor Health, LLC
Jul 16, 2015 Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutu... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutua... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 16, 2015 Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutu... Chemical Contamination; benzophenone leached from the product label varnish Class III Mutual Pharmaceutical Company, Inc.
Jul 15, 2015 SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0... Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... Class II GlaxoSmithkline Consmer Healthcare
Jul 15, 2015 biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (1... Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... Class II GlaxoSmithkline Consmer Healthcare
Jul 15, 2015 biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, Sou... Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... Class II GlaxoSmithkline Consmer Healthcare
Jul 15, 2015 biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tub... Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... Class II GlaxoSmithkline Consmer Healthcare
Jul 15, 2015 biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 ... Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... Class II GlaxoSmithkline Consmer Healthcare
Jul 15, 2015 SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech... Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... Class II GlaxoSmithkline Consmer Healthcare
Jul 15, 2015 SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufacture... Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... Class II GlaxoSmithkline Consmer Healthcare
Jul 15, 2015 SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured ... Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... Class II GlaxoSmithkline Consmer Healthcare
Jul 14, 2015 Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bott... Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown... Class III KVK-Tech, Inc.
Jul 13, 2015 Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch,... Failed dissolution specifications Class III Purdue Pharma L.P.
Jul 13, 2015 Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-coun... Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desme... Class I Life and More LLC
Jul 13, 2015 Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by P... Subpotent drug Class III Perrigo Israel Pharmaceuticals

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.