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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

Clear
DateProductReasonClassFirm
Jan 16, 2019 NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Jan 16, 2019 NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 ... Labeling: Label mix-up Class II KRS Global Biotechnology, Inc
Jan 15, 2019 infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m... Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. Class II Tris Pharma Inc.
Jan 15, 2019 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. Class II Tris Pharma Inc.
Jan 15, 2019 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. Class II Tris Pharma Inc.
Jan 15, 2019 Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, ... Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated ou... Class II LUPIN SOMERSET
Jan 15, 2019 HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodiu... Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/5... Class II Advanced Pharma Inc.
Jan 15, 2019 Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, M... Presence of Foreign Substance: Product complaint of black speckles observed on tablets. Class II Dr. Reddy's Laboratories, Inc.
Jan 11, 2019 Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufact... Defective Container; complaints of leakage. Class III Oxalis Labs
Jan 10, 2019 Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II MAJOR PHARMACEUTICALS
Jan 10, 2019 Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 m... Presence of Particulate Matter: filmy/cloudy particulate observed in vial. Class II McGuff Compounding Pharmacy Services, Inc.
Jan 9, 2019 Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lu... CGMP Deviations; presence of extraneous material in the was observed in area that is between the... Class II Lupin Pharmaceuticals Inc.
Jan 8, 2019 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Hap... Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... Class I Happy Together, Inc.
Jan 7, 2019 Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, ... CGMP Deviation; manufacturing batch record could not be located Class II Lupin Pharmaceuticals Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL ... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL L... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Jan 2, 2019 Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-7... CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... Class II Lupin Pharmaceuticals Inc.
Jan 2, 2019 Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, ... Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle Class II Heritage Pharmaceuticals, Inc.
Jan 2, 2019 Methocarbamol liquid 100mg/ml, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-7... CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... Class II Lupin Pharmaceuticals Inc.
Jan 2, 2019 Lidocaine gel 2%, RX, plastic dropper Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Glutathione liquid, 200mg/ml, Rx Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Lidocaine gel 1%, RX, plastic dropper Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 HCG liquid, 1000u/ml, RX, glass vial, various Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Testosteron Cypionate liquid 200mg/ml, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 0.2%, Rx, plastic dropper bottle Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 0.05%, Rx, plastic dropper bottle Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Vitamin B12 liquid 1000mcg/ml, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Glutathione liquid, 100mg/ml Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in... Subpotent Class II PharMEDium Services, LLC.
Jan 2, 2019 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. Class II Baxter Healthcare Corporation
Jan 2, 2019 Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include inj... Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Epinephrine liquid 1:1000, RX, glass vial Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 1%, Rx, plastic dropper bottle Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019 Cyclosporin liquid 0.5%, Rx, plastic dropper bottle Lack of sterility assurance. Class II Hiers Enterprises, LLC dba Northwest Compoundin...

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.