Browse Drug Recalls

2,157 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,157 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 2,157 FDA drug recalls.

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DateProductReasonClassFirm
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count... Chemical contamination: emission of strong odor after package was opened. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count... Chemical contamination: emission of strong odor after package was opened. Class II Pfizer Inc.
Mar 16, 2013 "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simeth... Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count ... Class II Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
Mar 14, 2013 Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infu... Non-Sterility; mold contamination Class I Med Prep Consulting, Inc.
Mar 14, 2013 All Compounded Products, packaged in plastic infusion bags, devices, syringes... Lack of Assurance of Sterility; potential for mold contamination Class II Med Prep Consulting, Inc.
Feb 15, 2013 Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) ... Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin ... Class II Dr Reddys Laboratories Tennessee LLC
Feb 15, 2013 Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg,... Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the produ... Class III Warner Chilcott Company LLC
Feb 15, 2013 Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg... Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the produ... Class III Warner Chilcott Company LLC
Feb 15, 2013 Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 ... Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the produ... Class III Warner Chilcott Company LLC
Feb 13, 2013 Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per... Chemical Contamination: The recall has been initiated based on multiple complaints received from ... Class III Glenmark Generics Inc., USA
Jan 23, 2013 Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz)... Cross Contamination with Other Products: Product was mixed with another type of mouth wash. Class III Procter & Gamble Hair Care Llc
Jan 17, 2013 Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and reli... Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminat... Class II Humco Holding Group, Inc
Dec 28, 2012 HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride ... Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria. Class II Hillyard GMP
Dec 21, 2012 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 m... Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeli... Class II Lee Pharmaceuticals, Inc
Dec 18, 2012 Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl... Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia ce... Class I Matrixx Initiatives Inc
Nov 29, 2012 NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for ... Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological sp... Class II Mariposa Labs, LLC
Oct 19, 2012 Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 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 Zovia (ethynodiol diacetate 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 Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, in... Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... Class II Watson Laboratories Inc
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.

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.