Browse Drug Recalls
2,021 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,021 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 2,021 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 13, 2012 | Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10... | Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... | Class II | West-ward Pharmaceutical Corp. |
| Apr 13, 2012 | Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m... | Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... | Class II | West-ward Pharmaceutical Corp. |
| Apr 9, 2012 | Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 50... | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl... | Class II | Dr. Reddy's Laboratories, Inc. |
| Apr 9, 2012 | Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By... | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl... | Class II | Dr. Reddy's Laboratories, Inc. |
| Mar 20, 2012 | DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distribut... | Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subp... | Class III | Quadrant Chemical Corporation |
| Mar 9, 2012 | Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX... | Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir ... | Class II | Aurobindo Pharma LTD |
| Mar 9, 2012 | Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufact... | Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is... | Class III | Pack Pharmaceuticals |
| Feb 24, 2012 | Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on t... | Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. | Class II | Lloyd Inc |
| Feb 3, 2012 | Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on... | Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. | Class II | Lloyd Inc |
| Oct 17, 2011 | Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC indus... | Labeling: Presence of Undeclared Color Additive; The product is being recalled because several in... | Class II | Meda Pharmaceuticals Inc. |
| Sep 27, 2011 | metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate... | Labeling: Label Mix up; product labeled did not indicated Extended Release | Class I | Shamrock Medical Solutions Group LLC |
| Sep 27, 2011 | Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to conta... | Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calc... | Class II | Shamrock Medical Solutions Group LLC |
| Sep 27, 2011 | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as M... | Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE... | Class I | Shamrock Medical Solutions Group LLC |
| Sep 27, 2011 | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiam... | Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules | Class I | Shamrock Medical Solutions Group LLC |
| Sep 27, 2011 | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx... | Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400... | Class II | Shamrock Medical Solutions Group LLC |
| Sep 27, 2011 | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to cont... | Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexo... | Class II | Shamrock Medical Solutions Group LLC |
| Jul 5, 2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... | Class II | Noven Pharmaceuticals, Inc. |
| Jan 19, 2011 | METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only... | Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," inste... | Class III | VistaPharm, Inc. |
| Nov 10, 2010 | Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, ... | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfa... | Class I | Physicians Total Care, Inc |
| Nov 10, 2010 | Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only,... | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfa... | Class I | Physicians Total Care, Inc |
| Mar 1, 2010 | Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... | Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit car... | Class II | K C Pharmaceuticals 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.