Browse Drug Recalls

1,152 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,152 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 1,152 FDA drug recalls in 2021.

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Date	Product	Reason	Class	Firm
Oct 12, 2021	TRI-MIX PAPAVERINE 26/PHENTOLAMINE 3/PGE-1 60/ML INJ 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 1/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	Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC...	CGMP Deviations: impurity N-nitrosoirbesartan detected in API	Class II	Lupin Pharmaceuticals Inc.
Oct 12, 2021	TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE,...	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 25 INJT 106 INJECTABLE, Rx on...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, T...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	HYDROXOCOBALAMIN 5,000MCG/ML INJ 5,000MCG/ML INJECTABLE, Rx only, Talon Compo...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 INJ ST 1 INJECTABLE, Rx ...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.5MG/ML IN OIL INJECTABLE, Rx only...	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 5 INJ INJECTABLE, Rx only, Talon...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 10/ATROPINE 0.15 INJ INJECTABLE, Rx only,...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials,...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.25MG/ML IN OIL INJECTABLE, Rx onl...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	MIC B COMPLEX W CHROMIUM/ METHYLCOB (BOYDEN) INJ INJECTABLE, Rx only, Talon ...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Co...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 100 INJ INJECTABLE, Rx only, Tal...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	MIC B12 25/50/50/1+B6 100 MG/ML INJ INJECTABLE, Rx only, Talon Compounding P...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TESTOSTERONE CYPIONATE 200MG/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 18/PHENTOL 0.6/PGE-1 6/ML INJ 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 1/PGE-1 12 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 0.5/PGE-1 20 INJ INJECTABLE, Rx only, Tal...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	ALPROSTADIL 22MCG/ML 22MCG/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 B12 25/50/50/0.5MG/ML L-CARNITINE 250MG/ML INJECTABLE, Rx only, Talon Co...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TRI-MIX PAPAVERINE 40/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 30/PHENTOLAMINE 4/PGE-1 7.5/ML INJ INJECTABLE, Rx only, ...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl...	CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same...	Class II	Teligent Pharma, Inc.
Oct 12, 2021	CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE, Rx only, Talon Compoundi...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, ...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 5.88/ML INJ 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 0.25/PGE-1 6 INJ INJECTABLE, Rx only, Tal...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	IC B COMPLEX INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thous...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl...	Superpotent Drug	Class I	Teligent Pharma, Inc.
Oct 12, 2021	TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABL...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TESTOSTERONE CYPIONATE 200MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Tal...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	ULTRA-TEST (CYP 80%/PROP 20%) 200MG/ML INJ #1 200MG/ML INJECTABLE, Rx only, T...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE,...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200MG/ML INJECTABLE, Rx only, Tal...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pha...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021	B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compoundin...	Lack of assurance of sterility	Class II	Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 8, 2021	Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured fo...	Out of specification result observed in a dissolution test at the 9-month long term stability tim...	Class II	Lupin Pharmaceuticals Inc.
Oct 5, 2021	Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S...	Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it ...	Class III	A-S Medication Solutions LLC.
Oct 5, 2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC ...	Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond...	Class II	Dr. Reddy's Laboratories, Inc.
Oct 5, 2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottle...	Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us...	Class II	Dr. Reddy's Laboratories, Inc.
Oct 5, 2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC ...	Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond...	Class II	Dr. Reddy's Laboratories, Inc.
Oct 5, 2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC ...	Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond...	Class II	Dr. Reddy's Laboratories, Inc.
Oct 5, 2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC ...	Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond...	Class II	Dr. Reddy's Laboratories, Inc.
Oct 5, 2021	Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole...	CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within ...	Class II	Dr. Reddy's Laboratories, Inc.
Oct 4, 2021	Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dro...	Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stabil...	Class II	Akorn, Inc.
Oct 1, 2021	LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can,...	Chemical Contamination: presence of benzene	Class I	Bayer Healthcare Pharmaceuticals 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.