DrugDatabase

Search FDA drug approvals, recalls, and adverse events. Real data from the openFDA API.

Latest Recalls

Class II2026-09-15
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with

Lack of Assurance of Sterility

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Class II2026-09-15
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5

Lack of Assurance of Sterility

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Not Yet Classified2026-09-14
Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Di

Failed Stability Specifications

SUN PHARMACEUTICAL INDUSTRIES INC
Not Yet Classified2026-09-11
0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.

Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeli

Otsuka ICU Medical LLC
Class II2026-09-04
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, In

Lack of Assurance of Sterility

Pfizer
Class II2026-09-03
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City L

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of th

OurPharma LLC
Class II2026-09-03
Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC

Failed Dissolution Specifications

Inventia Healthcare Limited
Class III2026-08-31
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solut

Failed dissolution specifications.

Supernus Pharmaceuticals, Inc.
View All Recalls

Recent Approvals

ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDEApproved 2026-07-22DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEApproved 2026-07-17NAVITRUXFOSAPREPITANTApproved 2026-06-24ROMIDEPSINROMIDEPSINApproved 2026-06-02GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATEApproved 2026-04-15ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEApproved 2026-03-20

Original approvals (new applications, including generics) granted in the last 12 months, from Drugs@FDA.

Quick Stats

18,002Drug Recall Records
20,692,690Adverse Event Reports (FAERS)

About this data

Everything on DrugDatabase comes from the openFDA API run by the U.S. Food and Drug Administration. Drug pages combine three openFDA datasets: Drugs@FDA (approved applications, sponsor, route and active substance), drug enforcement reports (recalls, with Class I being the most serious) and FAERS, the adverse event reporting system. The FDA refreshes enforcement reports weekly and FAERS quarterly; this site caches responses for up to an hour.

Start with a drug search by brand or generic name, browse the latest recalls by class, or look up the most reported reactions for a drug. Adverse event counts are reports, not proven side effects, and nothing here is medical advice.

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