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.

Clear
DateProductReasonClassFirm
Oct 26, 2021 Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) p... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 artnaturals Hand Sanitizer CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t... Class II VIRGIN SCENT INC
Oct 26, 2021 Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 25, 2021 Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Nort... Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the pro... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 25, 2021 Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Nor... Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the pro... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 22, 2021 Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Ph... Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 19, 2021 Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bot... Defective Container Class II Teligent Pharma, Inc.
Oct 19, 2021 Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bot... Defective Container Class II Teligent Pharma, Inc.
Oct 14, 2021 Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets,... Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... Class II Golden State Medical Supply Inc.
Oct 14, 2021 Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, M... Failed Excipient Specification; product manufactured using an excipient found to be OOS for condu... Class II Golden State Medical Supply Inc.
Oct 12, 2021 Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II Lupin Pharmaceuticals Inc.
Oct 12, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABL... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.25MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TESTOSTERONE CYPIONATE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, T... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 5 INJ INJECTABLE, Rx only, Talon... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TESTOSTERONE CYPIONATE 20MG/ML INJ #1 IN ETHYL OLEATE 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 1/PGE-1 2.5 INJ INJECTABLE, Rx only, Tal... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 MIC B COMPLEX INJ-MILES FORMULATION INJECTABLE, Rx only, Talon Compounding Ph... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon ... 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 40 INJ INJECTABLE, Rx only, Talo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 25MG/PHENTOLAMINE 1MG/PGE1 25MCG/ML INJ INJECTABLE, Rx o... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/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 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO ... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 25/PHENTOLAMINE 3/PGE-1 80 INJ INJECTABLE, Rx only, Talo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.75MG/ML IN OIL INJECTABLE, Rx onl... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABL... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML #2 IN SESAME OIL INJECTABLE, ... 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 30 INJ INJECTABLE, Rx only, Tal... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 LEUCINE 10MG/ ISOLEUCINE 15MG/ VALINE 40MG/ML (BCAA) INJ 10MG/15MG/40MG/ML IN... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TEST CYPIONATE 200MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Co... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, R... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 ALPROSTADIL 45MCG/ML 45MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmac... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 MIC B COMPLEX WITH HYDROXOCOBALAMIN 5MG/ML INJ INJECTABLE, Rx only, Talon C... 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 20 INJ **T 104** INJECTABLE, Rx o... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/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 MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML 20/40/50/25/25MG/ML INJECTABLE... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 15/PHENTOLAMINE 1/PGE-1 10 INJ INJECTABLE, Rx only, Talo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy

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.