Browse Drug Recalls

59 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 59 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 59 FDA drug recalls.

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DateProductReasonClassFirm
Dec 22, 2022 PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFI... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/3... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 293... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations

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.