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Recalls Safety

FDA Drug Recall Enforcement Dataset

FDA Drug Recall Enforcement Dataset

29,00 €

Work with FDA drug recall enforcement records in a versioned CSV and JSONL package with source-export context and provenance.

Purchase terms

Your purchase includes the edition described on this page. Later releases are separate unless this offer explicitly includes an update entitlement.

Source checks and new-release publication do not change the historical coverage or automatically add future editions to an earlier purchase.

Edition details

Edition
zf-037-2026-09-05-ba6b103bb268
Files
data/full.jsonl, data/full.csv, data/sample.json, schema.json, provenance.json, manifest.json, quality-report.json, LICENSE.md, README.md, CHANGELOG.md, sources/openfda-original.zip, sources/openfda-download-manifest.json, checksums.json
Formats
CSV, JSON, JSONL, MD, ZIP
Coverage
Complete drug enforcement bulk export published by openFDA on 2026-08-27, containing 17,899 recall records.
Geographic scope
Complete drug enforcement bulk export published by openFDA on 2026-08-27, containing 17,899 recall records.
Publisher
US FDA openFDA
Source updated
Explicitly unknown; see immutable provenance for the recorded source retrieval.
Source checked
2026-09-05T11:31:37.875812+00:00
Released
2026-09-05T11:31:37.875812+00:00
Licence and attribution
Source records remain subject to the original publisher terms linked in provenance.json. Retain attribution and source notices. Zentra grants use of the normalization, schema and packaging for internal and commercial analysis; this does not grant exclusive rights over public source facts or third-party material. No endorsement by source publishers.

View the publisher source

Schema

FieldTypeDescription
citystring
classificationstring
code_infostring
countrystring
distribution_patternstring
event_idstring
product_descriptionstring
product_quantitystring
product_typestring
reason_for_recallstring
recall_initiation_datestring
recall_numberstring
recalling_firmstring
report_datestring
source_urlstring
statestring
statusstring
termination_datenull|string

Sample preview

Open the public sample

cityclassificationcode_infocountrydistribution_patternevent_idproduct_descriptionproduct_quantityproduct_typereason_for_recallrecall_initiation_daterecall_numberrecalling_firmreport_datesource_urlstate
FlushingClass IAll lots within expiry.United StatesProduct was sold to individual consumers via ebay third party seller.98650Kian Pee Wan Capsules, 30-count bottles71 bottlesDrugsMarketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.20260321D-0769-2026Buy-Herbal20260819https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0769-2026NY
KadiClass IIBatch SDC2505001, Date of Expiry: April 30, 2030.IndiaDistributed Nationwide in the USA99547SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-0525KG, 250-1gm bagsDrugsCGMP Deviations:Noted during FDA inspection20260803D-0759-2026Shoolin Pharma Chem LLP20260819https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0759-2026
AustinClass ILot # 1984345, 1980571, 1981940, Use Before Date: 08/27/2026.United StatesUSA Nationwide99509Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.91DrugsMicrobial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.20260701D-0772-2026Victory Medical Center Pharmacy20260819https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0772-2026TX
ColumbiaClass IILot: AC-017271, Exp. 12/12/2026.United StatesNationwide within the U.S99505SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02250 vials.DrugsPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material20260729D-0753-2026Apollo Care, LLC20260819https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0753-2026MO
TarrytownClass IILot 2552A, Exp 09/30/2027United StatesNationwide in the USA.99532CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 339,060 15mL-bottlesDrugsLack of assurance of sterility. The recall is due to potential contamination20260729D-0766-2026Prestige Brands Holdings20260819https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0766-2026NY
ColumbiaClass IILot: AC-017108, Exp. 11/17/2026; AC-017110, Exp. 11/20/2026; AC-017112, Exp. 11/21/2026; AC-017142, AC-017144, Exp. 12/10/2026; AC-017166, AC-017167, AC-017177, AC-017213, AC-017224, AC-017225, Exp. 12/31/2026United StatesNationwide within the U.S99505SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-0556,918 vials.DrugsPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material20260729D-0747-2026Apollo Care, LLC20260819https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0747-2026MO
ColumbiaClass IILot: C-017115, Exp. 11/25/2026; AC-017163, Exp. 12/31/2026; AC-017169, AC-017170, AC-017171, Exp. 12/31/2026; AC-017230, AC-017231, Exp. 5/5/2027.United StatesNationwide within the U.S99505SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-0137,546 vials.DrugsPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material20260729D-0749-2026Apollo Care, LLC20260819https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0749-2026MO
ColumbiaClass IILot: AC-017273, Exp. 12/12/2026.United StatesNationwide within the U.S99505SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01250 vials.DrugsPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material20260729D-0755-2026Apollo Care, LLC20260819https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0755-2026MO
Category:

Analyse the drug-enforcement bulk export as a fixed, traceable dataset. The files support repeatable processing while retaining the source’s recall classifications and report context rather than reducing them to undated product labels.

What this download contains

This collection concerns drug recall enforcement, not adverse-event reports or clinical outcomes. The official export date and the package preparation date are distinct. Integrity checks establish properties of the files and processing, not independent medical validation of every upstream record.

Working with this edition

Review the schema and sample, load the export into your analysis environment and follow source references when examining a particular recall. Keep any aggregate findings tied to the edition and filter definitions used.

Product questions

Can I use this as an adverse-event dataset?

No. It is a recall enforcement export. Adverse-event reporting is a different source collection.

Does a record tell me what treatment to take?

No. This is reference data, not medical advice or a treatment recommendation.

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