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.

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Date	Product	Reason	Class	Firm
May 6, 2019	Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Ma...	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Class II	Zydus Pharmaceuticals USA Inc
May 6, 2019	Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manu...	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Class II	Zydus Pharmaceuticals USA Inc
May 6, 2019	MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: ...	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Class II	Zydus Pharmaceuticals USA Inc
May 6, 2019	Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactu...	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Class II	Zydus Pharmaceuticals USA Inc
May 3, 2019	Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA S...	Lack of assurance of sterility	Class II	Avella of Deer Valley, Inc. Store 38
May 3, 2019	Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured b...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
May 3, 2019	Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured b...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
May 3, 2019	Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufa...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
May 3, 2019	Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Ma...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
May 3, 2019	Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manuf...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Heritage Pharmaceuticals, Inc.
May 2, 2019	DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 P...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg ...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fe...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Si...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moi...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pin...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorph...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 c...	Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printe...	Class II	Septodont Inc.
May 2, 2019	DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guai...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 2, 2019	DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar P...	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination...	Class II	Unipharma, Llc.
May 1, 2019	Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Golden State Medical Supply Inc.
May 1, 2019	Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx on...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Golden State Medical Supply Inc.
May 1, 2019	Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx o...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Golden State Medical Supply Inc.
May 1, 2019	Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx onl...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Golden State Medical Supply Inc.
May 1, 2019	Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Golden State Medical Supply Inc.
Apr 30, 2019	Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL V...	Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufac...	Class II	Sagent Pharmaceuticals Inc
Apr 30, 2019	Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distribute...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Direct Rx
Apr 30, 2019	Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Onl...	Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product	Class I	Par Pharmaceutical, Inc.
Apr 30, 2019	Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and ...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Preferred Pharmaceuticals, Inc
Apr 29, 2019	Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per ...	Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax...	Class III	Pfizer Inc.
Apr 26, 2019	HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% ...	Sub-potency	Class II	Advanced Pharma Inc.
Apr 25, 2019	Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: C...	Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act...	Class II	Zydus Pharmaceuticals USA Inc
Apr 25, 2019	Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2...	Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rathe...	Class III	Advantice Health
Apr 25, 2019	Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2...	Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the n...	Class III	Advantice Health
Apr 25, 2019	Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malig...	Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during...	Class II	US Worldmeds LLC
Apr 25, 2019	Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by:...	Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg act...	Class II	Zydus Pharmaceuticals USA Inc
Apr 24, 2019	Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC ...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	AVKARE Inc.
Apr 24, 2019	Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC ...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	AVKARE Inc.
Apr 24, 2019	Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut...	CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found ...	Class II	Legacy Pharmaceutical Packaging LLC
Apr 24, 2019	DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-un...	cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.	Class II	MAJOR PHARMACEUTICALS
Apr 23, 2019	Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display box...	Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.	Class I	D.B.P. Distribution
Apr 23, 2019	Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per car...	Failed impurities/degradation specification: Out of Specification result for total impurity at 4....	Class III	Akorn Inc
Apr 22, 2019	Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 m...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with T...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soa...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 05857...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) ...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE San...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd

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.