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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 16, 2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 16, 2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, On... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 16, 2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz... | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contam... | Class II | Pharmatech LLC |
| Aug 2, 2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Aug 2, 2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, On... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Aug 2, 2017 | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Aug 2, 2017 | Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (23... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Aug 2, 2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl o... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Jul 17, 2017 | Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bott... | Microbial contamination of non-sterile products: product was found to contain mold, identified as... | Class II | Vi-Jon, Inc. |
| Jun 26, 2017 | Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-... | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | Class II | VistaPharm, Inc. |
| Jun 26, 2017 | Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-uni... | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | Class II | VistaPharm, Inc. |
| Jun 16, 2017 | Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 07... | Cross Contamination With Other Product: Imipramine | Class III | Sandoz Incorporated |
| Jun 13, 2017 | CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.... | Microbial Contamination of Non Sterile Products; out of specification Total Plate Count | Class II | Sigan Industries Inc. |
| Jun 6, 2017 | NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered s... | CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manu... | Class II | Bausch & Lomb, Inc. |
| Apr 24, 2017 | Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count... | Microbial Contamination of Non-Sterile Products | Class II | Teva Pharmaceuticals USA |
| Apr 18, 2017 | Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, ... | Microbial Contamination of Non-Sterile Products | Class II | Sun Pharmaceutical Industries, Inc. |
| Mar 21, 2017 | Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) p... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 17, 2017 | Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx on... | Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be cont... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Mar 10, 2017 | Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Clar... | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... | Class II | Claris Lifesciences Inc |
| Mar 10, 2017 | Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only... | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... | Class II | Claris Lifesciences Inc |
| Mar 10, 2017 | Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, ... | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... | Class II | Claris Lifesciences Inc |
| Mar 10, 2017 | Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Clari... | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... | Class II | Claris Lifesciences Inc |
| Mar 7, 2017 | Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manuf... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manuf... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx ... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, ... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manuf... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 6, 2017 | RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. B... | Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsul... | Class III | Dr. Reddy's Laboratories, Inc. |
| Mar 1, 2017 | Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectr... | Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial conta... | Class II | Signature Club A Ltd |
| 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 |
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.