Browse Drug Recalls
2,138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,138 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 2,138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 19, 2012 | Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg,... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| Oct 19, 2012 | Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, ... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| Sep 21, 2012 | 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Ba... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
| Sep 21, 2012 | Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, produ... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
| Sep 21, 2012 | Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | American Enterprises LLC dba Sterling Gelatin |
| Sep 21, 2012 | 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product cod... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
| Sep 21, 2012 | 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVI... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
| Sep 21, 2012 | 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, pr... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
| Sep 17, 2012 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective ag... | Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count ab... | Class II | DermaCare, Inc. |
| Sep 17, 2012 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective ag... | Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count ab... | Class II | DermaCare, Inc. |
| Sep 4, 2012 | Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Re... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Su... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber ... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natura... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psylli... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fib... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Cap... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. b... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy fo... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Sep 4, 2012 | Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Su... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | Raritan Pharmaceuticals, Inc. |
| Aug 7, 2012 | Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactu... | Cross Contamination w/Other Products: During stability testing chromatographic review revealed ex... | Class II | Mylan Pharmaceuticals Inc. |
| Aug 1, 2012 | Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. R... | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 1, 2012 | Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. ... | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 1, 2012 | Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. R... | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 27, 2012 | Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 f... | Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkh... | Class III | Natural Essentials Inc |
| Jul 27, 2012 | Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rin... | Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphing... | Class II | Capco Custom Packaging Inc |
| Jul 13, 2012 | CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g... | Microbial Contamination of Non Sterile Product; mold | Class II | Island Kinetics dba Covalence |
| Jun 14, 2012 | Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Lit... | Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated ... | Class II | Kimberly-Clark Corporation |
| Jun 14, 2012 | ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (eff... | Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufact... | Class II | Dukal Corp. |
| Jun 14, 2012 | Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl o... | Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated ... | Class II | Kimberly-Clark Corporation |
| Jun 14, 2012 | Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.... | Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufact... | Class II | Dukal Corp. |
| Jun 7, 2012 | Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only.... | Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di... | Class III | Fougera Pharmaceuticals, Inc. |
| May 8, 2012 | Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg ... | Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due... | Class II | Bayer HealthCare Pharmaceuticals Inc. |
| Feb 8, 2012 | Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distri... | Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole. | Class II | Physicians Total Care, Inc. |
| Feb 10, 2011 | Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), ... | Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (782... | Class III | Abc Compounding Company Inc |
| Feb 8, 2011 | Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by B... | Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA). | Class III | Physicians Total Care, 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.