Browse Drug Recalls

65 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 65 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 65 FDA drug recalls.

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DateProductReasonClassFirm
Feb 12, 2015 Phenylephrine 0.5% Solution (Bottle), Health Innov Pharmacy, 295 Pinehurst Av... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Nortriptyline 10 mg/5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Sout... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream, Health Innov Pharmacy, 295 Pi... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Nadolol 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern P... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Ibuprofen 10% cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Sodium Tetradecyl 1% Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Sou... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Progest 200 mg/1 mL Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Pregnenolone 20 mg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Sout... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE ... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 DHEA 10 mg SR Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Naltrexone 4.5 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pi... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pi... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Phen 15 mg - Topri 92 mg SR Cap (Qsymia), Health Innov Pharmacy, 295 Pinehurs... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Methylcobalamin 1000 mcg/mL Injection, Health Innov Pharmacy, 295 Pinehurst A... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Glycerin 98.5% Opth. Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Sout... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, 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.