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Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Apr 2, 2019 HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hw... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City H... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Blu... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compoundi... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluf... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anders... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 B... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy,... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL S... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Ander... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 40 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bl... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bl... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bris... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Phar... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Methylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 3... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottl... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Papaverine 30 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City H... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Phar... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Mar 29, 2019 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on ... Class II Jubilant Cadista Pharmaceuticals, Inc.
Mar 25, 2019 Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. ... Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. Class II Lohxa LLC
Mar 25, 2019 Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.... Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. Class II Lohxa LLC
Mar 25, 2019 Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufacture... Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. Class II Glenmark Pharmaceuticals Inc., USA
Mar 22, 2019 Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg,... Failed Impurities/Degradation Specifications: Out-of-specification results observed in related su... Class II Lupin Pharmaceuticals Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial,... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 19, 2019 Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... cGMP Deviations Class II Allergan Sales, LLC
Mar 19, 2019 Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chlor... Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon... Class II LUPIN SOMERSET
Mar 14, 2019 Losartan 50mg Tablet, 30 count each blister card. CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmace... Class II RemedyRepack Inc.
Mar 13, 2019 Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 3... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, Q... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile singl... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, ... Lack of Assurance of Sterility Class II Advanced Pharma 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.