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Browse Drug Recalls

989 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 989 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 989 FDA drug recalls in TN.

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DateProductReasonClassFirm
Feb 27, 2015 Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Man... Subpotent Drug Class III AVKARE Inc.
Feb 27, 2015 Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Ma... Subpotent Drug Class III AVKARE Inc.
May 12, 2014 CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chlorid... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Ribofl... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Liver Derivative Complex for injection, each mL contains: Liver Derivative Co... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Ch... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Steril... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Wat... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL,... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
Apr 9, 2014 THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Coun... Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. Class I Nature's Universe
Mar 17, 2014 Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Ph... Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. Class III John W Hollis Inc
Mar 17, 2014 Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, N... Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. Class II John W Hollis Inc
Mar 17, 2014 Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pha... Presence of Particulate Matter Class II John W Hollis Inc
Mar 17, 2014 Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial... Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. Class III John W Hollis Inc
Aug 23, 2013 CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL ... CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was... Class II Central Shared Services dba Parallon
Jul 18, 2013 ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, ... Microbial Contamination of Non-Sterile Products: This product is being recalled because a stabili... Class III Vi-Jon, Inc.
May 28, 2013 Mitomycin 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbe... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 5000iu kit, Main Street Compounding Pharmacy, 126 East Main Street, Newbe... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 5,000U, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, ... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Sermorelin 3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbe... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 3000IU, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, ... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Amikacin 500mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, N... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Mic w/B6/B12/Lido 50ml, Main Street Compounding Pharmacy, 126 East Main Stree... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Testosterone Cypionate/Testosterone Propionate 250mg 10ml, Main Street Compou... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Testosterone Pellets 25mg, Main Street Compounding Pharmacy, 126 East Main St... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 220 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Alprostadil 40mg, Main Street Compounding Pharmacy, 126 East Main Street, New... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Mesotherapy, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Lipo B (Mic w/B5/B6/B12+Lido), Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Testosterone Cypionate 200mg/ml, 10ml Main Street Compounding Pharmacy, 126 E... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Lipotropic 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newb... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Testosterone Pellets 200mg, Main Street Compounding Pharmacy, 126 East Main S... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Methylcob 100mcg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Str... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Bacteriostatic Water 30ml, Main Street Compounding Pharmacy, 126 East Main St... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 290 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 B-12 0.5ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Lincomycin 300mg, Main Street Compounding Pharmacy, 126 East Main Street, New... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 300 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC

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.