Browse Drug Recalls

23 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 23 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 23 FDA drug recalls.

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DateProductReasonClassFirm
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
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

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.