Browse Drug Recalls
1,732 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,732 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 1,732 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 26, 2012 | Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL an... | Non-Sterility | Class I | New England Compounding Center |
| Sep 26, 2012 | Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL a... | Non-Sterility | Class I | New England Compounding Center |
| Sep 21, 2012 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count... | Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tabl... | Class I | Watson Laboratories Inc |
| Sep 20, 2012 | SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Pr... | Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppr... | Class I | Globe All Wellness, LLC |
| Sep 10, 2012 | HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-coun... | Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets result... | Class I | Vintage Pharmaceuticals LLC DBA Qualitest Pharm... |
| Aug 31, 2012 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hosp... | Presence of Particulate Matter; product may contain fibrous material | Class I | Hospira Inc. |
| Aug 29, 2012 | BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactu... | Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine v... | Class I | Bristol-myers Squibb Company |
| Aug 27, 2012 | Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information ... | Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets beca... | Class I | Samantha Lynn, Inc |
| Aug 23, 2012 | Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Laud... | Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredien... | Class I | Evol Nutrition |
| Aug 23, 2012 | Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Hea... | Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredien... | Class I | Evol Nutrition |
| Aug 15, 2012 | HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject pr... | Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfille... | Class I | Hospira Inc. |
| Jul 30, 2012 | Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20... | Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials ... | Class I | Genentech Inc |
| Jul 16, 2012 | Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792... | Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sil... | Class I | Coral Rock Man, Inc. |
| Jul 16, 2012 | X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 1... | Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sil... | Class I | Coral Rock Man, Inc. |
| Jun 26, 2012 | Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg... | Presence of Particulate Matter | Class I | Ben Venue Laboratories Inc |
| May 25, 2012 | V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 280... | Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafi... | Class I | The Menz Club, LLC |
| May 18, 2012 | a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules bl... | Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tada... | Class I | InSo-Independent Contractor for West Coast Nutr... |
| May 12, 2012 | HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject pr... | Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be... | Class I | Hospira Inc. |
| Apr 21, 2012 | X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distri... | Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hyd... | Class I | XRock Industries, LLC |
| Apr 17, 2012 | Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartr... | Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL | Class I | Hospira Inc. |
| Mar 10, 2012 | Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS | Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of s... | Class I | The Menz Club, LLC |
| Feb 23, 2012 | Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipo... | Marketed Without an Approved ANDA/NDA: presence of sibutramine | Class I | www.vitaminbestbuy.com |
| Feb 23, 2012 | Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American ... | Marketed Without an Approved ANDA/NDA: presence of sildenafil. | Class I | www.vitaminbestbuy.com |
| Feb 23, 2012 | Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: Ameri... | Marketed Without an Approved ANDA/NDA: presence of sildenafil | Class I | www.vitaminbestbuy.com |
| Dec 19, 2011 | Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, ... | Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA... | Class I | Body Basics Inc |
| Dec 2, 2011 | Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion O... | A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a s... | Class I | Eagle 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 | 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 |
| 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 |
| Feb 24, 2006 | Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution,... | Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be conta... | Class I | Merit Medical Systems, 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.