Browse Drug Recalls

2,097 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,097 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 2,097 FDA drug recalls in NJ.

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Date	Product	Reason	Class	Firm
May 6, 2019	The Beast, The Beast can be taken under the situation of Heart disease and ev...	Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discove...	Class I	Stiff Boy LLC
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 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 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 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 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.
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 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	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	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 22, 2019	AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium ch...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Fo...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by...	Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substan...	Class III	Zydus Pharmaceuticals USA Inc
Apr 22, 2019	Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a...	CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra...	Class II	Inopak Ltd
Apr 22, 2019	Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel...	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
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	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	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	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	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 19, 2019	FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx...	Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 ...	Class I	Alvogen, Inc
Apr 18, 2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Torrent Pharma Inc.
Apr 18, 2019	Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)10...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Torrent Pharma Inc.
Apr 18, 2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-co...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Torrent Pharma Inc.
Apr 18, 2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-c...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Torrent Pharma Inc.
Apr 18, 2019	Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)10...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Torrent Pharma Inc.
Apr 18, 2019	Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	Torrent Pharma Inc.
Apr 11, 2019	Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (...	cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.	Class II	Dr. Reddy's Laboratories, Inc.
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only,...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only,...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufac...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only,...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 2, 2019	Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, pr...	Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.	Class III	Johnson Matthey Inc.
Mar 28, 2019	Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, M...	Presence of Particulate Matter: One vial was found to contain a hair.	Class I	Aurobindo Pharma USA Inc.
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 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 7, 2019	Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace...	CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)...	Class II	Rising Pharmaceuticals, Inc.
Mar 7, 2019	Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace...	CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)...	Class II	Rising Pharmaceuticals, Inc.
Mar 7, 2019	Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Heal...	CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)...	Class II	Rising Pharmaceuticals, Inc.
Mar 7, 2019	Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Ace...	CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)...	Class II	Rising Pharmaceuticals, Inc.
Mar 6, 2019	Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx onl...	Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterilit...	Class II	Dr. Reddy's Laboratories, Inc.
Feb 28, 2019	Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-cou...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i...	Class II	Torrent Pharma Inc.
Feb 28, 2019	LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i...	Class II	Torrent Pharma Inc.
Feb 28, 2019	LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 9...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i...	Class II	Torrent Pharma Inc.
Feb 28, 2019	LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) ...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i...	Class II	Torrent Pharma Inc.
Feb 28, 2019	Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90...	CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ...	Class II	Camber Pharmaceuticals Inc
Feb 28, 2019	Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-coun...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i...	Class II	Torrent Pharma Inc.
Feb 28, 2019	Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-co...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i...	Class II	Torrent 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.