Browse Drug Recalls
1,720 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,720 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 1,720 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 7, 2017 | Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, In... | Superpotent Drug | Class III | Teligent, Inc. |
| Apr 4, 2017 | Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by ... | Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with ill... | Class III | West-Ward Columbus, Inc. |
| Mar 28, 2017 | PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL b... | Failed Stability Specifications | Class III | Teva Pharmaceuticals USA |
| Mar 22, 2017 | Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83... | Failed Impurities/Degradation Specifications: out of specification results for the related substa... | Class III | Sun Pharmaceutical Industries, Inc. |
| Mar 22, 2017 | Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corp. |
| Mar 22, 2017 | Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun ... | Failed Impurities/Degradation Specifications: out of specification results for the related substa... | Class III | Sun Pharmaceutical Industries, Inc. |
| Mar 22, 2017 | Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83)... | Failed Impurities/Degradation Specifications: out of specification results for the related substa... | Class III | Sun Pharmaceutical Industries, Inc. |
| Mar 22, 2017 | Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83)... | Failed Impurities/Degradation Specifications: out of specification results for the related substa... | Class III | Sun Pharmaceutical Industries, Inc. |
| Mar 22, 2017 | Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles,... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corp. |
| Mar 20, 2017 | CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 ... | Discoloration. | Class III | Valeant Pharmaceuticals North America LLC |
| Mar 20, 2017 | CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotio... | Discoloration. | Class III | Valeant Pharmaceuticals North America LLC |
| Mar 20, 2017 | Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638... | Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. | Class III | G & W Laboratories, 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 16, 2017 | Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Phar... | Subpotent Drug | Class III | Fresenius Kabi USA, LLC |
| Mar 16, 2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Alle... | Failed Impurities/Degradation Specifications | Class III | Allergan Sales, LLC |
| 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 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750... | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... | Class III | Pfizer 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 | Indian God Lotion Spray Bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate... | Class III | A&H Focal 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 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300... | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... | Class III | Pfizer Inc |
| Mar 7, 2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900... | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... | Class III | Pfizer 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. |
| Feb 28, 2017 | Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicat... | CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. | Class III | G & W Laboratories, Inc. |
| Feb 24, 2017 | Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles... | Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potas... | Class III | Citron Pharma Llc |
| Feb 22, 2017 | Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not f... | Chemical Contamination | Class III | Novel Laboratories, Inc. |
| Feb 21, 2017 | A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) ... | Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a label... | Class III | Bayer HealthCare Pharmaceuticals, Inc. |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Servi... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... | Failed Dissolution Specifications: low out of specification dissolution results found during stab... | Class III | Teva Pharmaceuticals USA |
| Feb 17, 2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service C... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Servic... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service C... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Servic... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Servic... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 15, 2017 | Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 1... | Failed dissolution specifications - low dissolution results at S3 stage. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 1... | Failed dissolution specifications - low dissolution results at S3 stage. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 1... | Failed dissolution specifications - low dissolution results at S3 stage. | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 15, 2017 | Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services 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.