Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Zenatane (isotretinoin) capsules, 20 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 13, 2017 | Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruh... | Failed Impurities/Degradation Specifications: The API for these products had an out of specificat... | Class III | L. Perrigo Company |
| Feb 13, 2017 | Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Y... | Failed Impurities/Degradation Specifications: The API for these products had an out of specificat... | Class III | L. Perrigo Company |
| Feb 13, 2017 | PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TO... | Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. | Class III | Colgate Palmolive Co |
| Feb 7, 2017 | Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx... | Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at... | Class III | Actavis Inc |
| Feb 2, 2017 | Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Cover... | Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Ca... | Class III | Sage Products 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. |
| Jan 27, 2017 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 ... | Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of... | Class III | Pharmedium Services, LLC |
| Jan 16, 2017 | Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, ... | Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-... | Class III | LEO PHARMA INC |
| Jan 16, 2017 | DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for:... | Failed Impurities/ Degradation Specifications | Class III | Vintage Pharmaceuticals LLC dba Qualitest Pharm... |
| Jan 12, 2017 | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vial... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Actavis Inc |
| Jan 7, 2017 | Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for... | Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue ... | Class III | Hetero USA Inc |
| Jan 5, 2017 | Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, ... | Subpotent | Class III | InnovaGel |
| Jan 5, 2017 | Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swi... | Subpotent | Class III | InnovaGel |
| Jan 4, 2017 | Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ... | Supotent: Out of Specification result for assay test during routine stability testing. | Class III | Mckesson Packaging Services |
| Dec 29, 2016 | Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : ... | Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of p... | Class III | Hetero Drugs Ltd. - Unit 1 |
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.