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Browse Drug Recalls

534 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 534 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 534 FDA drug recalls in 2012.

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DateProductReasonClassFirm
Oct 3, 2012 Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., M... Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (ex... Class II Paddock Laboratories, LLC
Sep 28, 2012 Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%)... CGMP Deviations: The products were manufactured with raw material which contain unknown particles... Class III ITW Dymon
Sep 27, 2012 ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single D... Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Class II Fresenius Kabi USA, LLC
Sep 27, 2012 Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd B... Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 mon... Class II Dr. Reddy's Laboratories, Inc.
Sep 27, 2012 CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-co... Short Fill: some bottles contained less than 120-count per labeled claim. Class III Genentech, Inc.
Sep 27, 2012 MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vi... Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Class II Fresenius Kabi USA, LLC
Sep 27, 2012 CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2... Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Class II Fresenius Kabi USA, LLC
Sep 26, 2012 Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New E... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/m... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL a... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Comp... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL an... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufact... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Pho... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 ... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manu... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 m... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compo... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufact... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Comp... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL a... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Comp... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL an... Non-Sterility Class I New England Compounding Center
Sep 21, 2012 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, pr... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVI... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product cod... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II American Enterprises LLC dba Sterling Gelatin
Sep 21, 2012 Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, produ... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Ba... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count... Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tabl... Class I Watson Laboratories Inc
Sep 20, 2012 Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manuf... Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacycl... Class III Sandoz Incorporated
Sep 20, 2012 Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genente... Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin A... Class II Genentech Inc
Sep 20, 2012 Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genente... Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin A... Class II Genentech Inc
Sep 20, 2012 SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Pr... Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppr... Class I Globe All Wellness, LLC
Sep 17, 2012 UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective ag... Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count ab... Class II DermaCare, Inc.
Sep 17, 2012 UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective ag... Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count ab... Class II DermaCare, Inc.
Sep 12, 2012 Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx... Impurities/Degradation Products: An out of specification result for a known impurity of the produ... Class III Sandoz Incorporated
Sep 12, 2012 Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, R... Impurities/Degradation Products: An out of specification result for a known impurity of the produ... Class III Sandoz Incorporated
Sep 10, 2012 HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-coun... Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets result... Class I Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Sep 6, 2012 Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, ... CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substitu... Class II Church & Dwight Inc
Sep 5, 2012 Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (rec... Lack of Assurance of Sterility; container closure issues with the bulk batch. Class II F. Hoffmann-LaRoche Ltd.
Sep 4, 2012 Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Su... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy fo... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. b... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Cap... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fib... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psylli... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natura... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, 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.