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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
Oct 12, 2021 TRI-MIX PAPAVERINE 23.3/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Ta... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 30 INJ INJECTABLE, Rx only, Talo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.75MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials,... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #2 IN SESAME OIL INJECT... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thous... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #1 IN ETHYL OLEATE INJE... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 MEDROXYPROGESTERONE ACET 150MG/ML SUSP (PF) 150MG/ML SUSPENSION, Rx only, Ta... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 10 INJ INJECTABLE, Rx only, Tal... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 60 INJ INJECTABLE, Rx only, Talo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 HYDROXOCOBALAMIN 1,000MCG/ML INJ VIAL 1,000MCG/ML INJECTABLE, Rx only, Talon... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.75MG/ML IN OIL INJECTAB... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 4, 2021 Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dro... Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stabil... Class II Akorn, Inc.
Sep 27, 2021 Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 S... Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of steril... Class II AMIVAS (US), LLC
Sep 22, 2021 Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx O... Lack of Assurance of Sterility Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Sep 22, 2021 Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial... Lack of Assurance of Sterility Class II New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Sep 17, 2021 ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, I... Lack of sterility assurance. Class II IntegraDose Compounding Services LLC
Sep 17, 2021 Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only,... Defective container: Cracked vials leading to lack of sterility assurance Class II Fresenius Kabi USA LLC
Sep 17, 2021 ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Prod... Lack of sterility assurance. Class II IntegraDose Compounding Services LLC
Sep 8, 2021 TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 3... Lack of Assurance of Sterility Class II Akorn, Inc.
Aug 27, 2021 Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Conta... Lack of Assurance of Sterility Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation On... Lack of Assurance of Sterility Class II Glenmark Pharmaceuticals Inc., USA
Aug 18, 2021 Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Green... Lack of Assurance of Sterility Class II Prescription Labs Inc dba Greenpark
Aug 13, 2021 FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compoundin... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mounta... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mounta... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...

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.