Browse Drug Recalls

2,138 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,138 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 2,138 FDA drug recalls.

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DateProductReasonClassFirm
Aug 8, 2016 Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: M... CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... Class II Pharmatech LLC
Aug 1, 2016 Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and ... Non-Sterility; microbial contamination identified as Bacillus circulans Class I Town and Country Compounding and Consultation S...
Jul 29, 2016 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further p... CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... Class II Sage Products LLC
Jul 29, 2016 COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia ce... Class I Sage Products LLC
Jul 29, 2016 COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... Class II Sage Products LLC
Jul 25, 2016 Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) ... Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia Class I US Compounding Inc
Jul 18, 2016 Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoS... Penicillin Cross Contamination Class II GlaxoSmithKline, LLC
Jul 18, 2016 Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmi... Penicillin Cross Contamination Class II GlaxoSmithKline, LLC
Jul 18, 2016 Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx... Penicillin Cross Contamination Class II GlaxoSmithKline, LLC
Jul 18, 2016 Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSm... Penicillin Cross Contamination Class II GlaxoSmithKline, LLC
Jul 15, 2016 Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint ... Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia Class I The Harvard Drug Group
May 13, 2016 Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottl... Chemical Contamination: Bottles may contain broken dessicants Class III Virtus Pharmaceuticals, Llc
Apr 4, 2016 BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. ... Microbial Contamination of Non-Sterile Products: Failed S.aureus test. Class II Keystone Laboratories Inc
Mar 25, 2016 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun... Non-Sterility: fungal contamination due to leaking containers. Class I B. Braun Medical Inc
Mar 8, 2016 Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Ho... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hos... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hos... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Ho... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx on... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, In... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 1, 2016 Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Sing... Cross contamination with other products: metronidazole Class II Sagent Pharmaceuticals Inc
Feb 8, 2016 Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ... Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus au... Class II Keystone Laboratories Inc
Dec 22, 2015 Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Sp... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spr... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Dec 22, 2015 Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, ... Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... Class II Grato Holdings, Inc.
Nov 12, 2015 tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ... Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found ... Class II Mariposa Labs LLC
Nov 11, 2015 SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle spe... Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are bei... Class II Fagron, Inc
Nov 11, 2015 SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspe... Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are bei... Class II Fagron, Inc
Nov 11, 2015 SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-... Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are bei... Class II Fagron, Inc
Oct 1, 2015 Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric a... Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... Class III Tribute Pharmaceuticals US Inc.
Oct 1, 2015 Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fen... Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the... Class III Tribute Pharmaceuticals US Inc.
Sep 22, 2015 Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20... Cross Contamination With Other Products: Potential cross-contamination of cephalosporin. Class II Midway Importing, Inc
Sep 10, 2015 ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays... Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. Class III EMD Serono, Inc.
Sep 4, 2015 Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare ... Chemical Contamination: Naphthalene compound identified in the product after complaints of a petr... Class II Healthpoint, Ltd
Aug 13, 2015 Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by... Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... Class II GlaxoSmithKline, LLC.
Aug 13, 2015 Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) ... Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... Class II GlaxoSmithKline, LLC.
Aug 13, 2015 Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC ... Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... Class II GlaxoSmithKline, LLC.
Aug 13, 2015 Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactur... Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... Class II GlaxoSmithKline, LLC.
Aug 6, 2015 DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isop... Chemical contamination: Product may be contaminated with a toxic compound. Class II 3M Company - Health Care Business
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 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, 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 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 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, 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.
Jun 22, 2015 c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL R... Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used t... Class II Solutions Rx Pharmacy
Jun 8, 2015 TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy 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.