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Browse Drug Recalls

50 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 50 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 50 FDA drug recalls.

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DateProductReasonClassFirm
Mar 20, 2013 Test cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy,... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 3... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 25 mg-Estadiol valerate 15 mg/mL, Clinical Specialties Compounding P... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Ba... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, A... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Roa... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Roa... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 10 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 B... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 B... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 B... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy,... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 31... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmac... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 B... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmac... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Basto... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Basto... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Bast... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Injection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Bas... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Ro... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Ba... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 11, 2013 Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Speci... Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye i... Class II Clinical Specialties Compounding Pharmacy

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.