Browse Drug Recalls

2,012 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,012 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 2,012 FDA drug recalls.

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DateProductReasonClassFirm
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.