Browse Drug Recalls
2,151 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,151 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 2,151 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 22, 2017 | Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not f... | Chemical Contamination | Class III | Novel Laboratories, Inc. |
| Jan 30, 2017 | Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 bli... | Chemical Contamination: out of specification results for impurities were found to be the result o... | Class III | Mylan Pharmaceuticals Inc. |
| Jan 30, 2017 | Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and ... | Chemical Contamination: out of specification results for impurities were found to be the result o... | Class III | Mylan Pharmaceuticals Inc. |
| Dec 28, 2016 | Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only,... | Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of... | Class II | L. Perrigo Company |
| Nov 9, 2016 | Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01),... | Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence o... | Class II | VistaPharm, Inc. |
| Sep 9, 2016 | Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankles... | Microbial Contamination of Non-Sterile Product | Class II | Cadila Pharmaceuticals Limited |
| Sep 2, 2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... | Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. | Class I | United Exchange Corporation |
| Aug 8, 2016 | Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. ... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bay... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg i... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by:... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| 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 |
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.