Browse Drug Recalls

1,018 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,018 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 1,018 FDA drug recalls in NY.

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DateProductReasonClassFirm
Oct 27, 2015 Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-3... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) ,... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx ... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 26, 2015 Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct ... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Par Pharmaceutical Inc.
Oct 26, 2015 Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bot... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Par Pharmaceutical Inc.
Sep 24, 2015 Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed b... Subpotent Drug Class II Pfizer Inc.
Sep 17, 2015 WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External An... Labeling: Incorrect Instructions; The word not is missing from the following sentences "do band... Class II The Mentholatum Co.
Aug 21, 2015 Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx o... Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the... Class III Silarx Pharmaceutical, Inc.
Jul 28, 2015 Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsule... Failed Dissolution Specifications: Product is being recalled due to out of specification (above s... Class III Novartis Pharmaceuticals Corp.
Jun 8, 2015 HYDROXOCOBALAMIN Injection, Rx, compounded by Life Science Pharmacy Inc., Har... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 TRI-EST Liquids, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 2-DEOXY-D-GLUCOSE Powder, Rx, compounded by Life Science Pharmacy Inc., Harri... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Face Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Suppositories, Rx, compounded by Life Science Pharmacy Inc., Harriman... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Vaginal Creams, Rx, compounded by Life Science Pharmacy Inc., Harrima... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life S... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harrima... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Suspensions, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science ... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 5, 2015 Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (... CGMP Deviation: Poor container closure of the bulk storage container Class III Geritrex Corp
May 22, 2015 Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
May 22, 2015 Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA L... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
May 21, 2015 SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: In... Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey ... Class II Medtech Products, Inc.
May 12, 2015 Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and l... CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer c... Class II Allegiant Health
Apr 10, 2015 MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-D... Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include on... Class III Medtech Products, Inc.
Mar 17, 2015 Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon W... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Well... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellne... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 300... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmac... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mc... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fal... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon We... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.

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.