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FDA Drug/Device Safety Verification

4 real rows pulled directly from the full dataset, unedited — the actual field structure and content a buyer receives. The full purchase includes all 40 rows.

Row 1 of 40
row_id
FDS01
claim
In 2019-2020, ranitidine (Zantac) was recalled nationwide by multiple manufacturers because FDA testing found the drug contained NDMA, a probable human carcinogen, and the FDA ultimately requested removal of all ranitidine products from the U.S. market on April 1, 2020.
claim_source_url
https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
verification_method
openfda_drug_enforcement
verified_value
openFDA drug/enforcement.json search "product_description:ranitidine" returns 100 real enforcement records. One example, recall_number D-0643-2020 (Glenmark Pharmaceuticals Inc., USA), reason_for_recall: "CGMP Deviations: Presence of NDMA impurity detected in product." — recall_initiation_date 20191217, center_classification_date 20200105, classification Class II.
verification_source_url
https://api.fda.gov/drug/enforcement.json?search=product_description%3A%22ranitidine%22&limit=5
agreement
match
explanation
Called fda.searchDrugRecalls('ranitidine') against the live openFDA drug/enforcement.json endpoint. It returned 100 total ranitidine enforcement records; the 5 shown on this page alone span 4 distinct recalling firms (Glenmark Pharmaceuticals Inc., USA, Mckesson Packaging Services, Dr. Reddy's Laboratories, Inc., Novitium Pharma LLC). CORRECTION (2026-07-12 adversarial audit): this explanation originally said "every one citing NDMA contamination as the reason" — re-running the identical live query shows 4 of the 5 first-page records cite NDMA; the fifth, D-0914-2018 (Mckesson Packaging Services), is a 2018 ranitidine recall for "Failed Stability Specifications" that predates the 2019-2020 NDMA wave entirely and does not mention NDMA. The claim itself is unaffected (it concerns the 2019-2020 NDMA recalls, all confirmed). Recall D-0643-2020's reason_for_recall field reads verbatim "CGMP Deviations: Presence of NDMA impurity detected in product." — an exact, independently-checkable confirmation of the claimed mechanism (NDMA, not a different contaminant). The claim's broader "FDA requested removal of all ranitidine" framing matches the well-documented April 1, 2020 FDA market withdrawal request, which is a distinct FDA action from (and came after) the individual manufacturer recalls this endpoint records one-by-one.
model_tested
claude-sonnet-5
model_question
Why was ranitidine (Zantac) recalled from the U.S. market in 2019-2020, and when did the FDA request its complete removal from sale?
model_response
Ranitidine was recalled because testing found it could contain N-nitrosodimethylamine (NDMA), a probable human carcinogen, with levels that could increase over time or when stored at higher temperatures, and could be higher than acceptable limits especially in older stock. Manufacturers began voluntary recalls in 2019, and the FDA requested that all remaining ranitidine products (prescription and OTC, including Zantac) be withdrawn from the U.S. market in April 2020.
model_verdict
correct
model_grading_note
Matches verified NDMA mechanism and April 2020 FDA removal date exactly.
grading_mode
judge
difficulty
easy
tags
[
  "recall",
  "ndma",
  "fda",
  "zantac"
]
Row 2 of 40
row_id
FDS02
claim
Starting in mid-2020, several generic manufacturers (including Amneal, Marksans/Time-Cap, and Teva/Actavis) recalled specific lots of metformin hydrochloride extended-release tablets after FDA testing found levels of the probable carcinogen NDMA above the acceptable intake limit.
claim_source_url
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin
verification_method
openfda_drug_enforcement
verified_value
Of 137 live recall records matching reason_for_recall:"NDMA", 10 shown here are metformin ER recalls; example D-1349-2020 (Amneal Pharmaceuticals of New York, LLC), reason_for_recall: "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level", classification Class II, recall_initiation_date 20200529.
verification_source_url
https://api.fda.gov/drug/enforcement.json?search=reason_for_recall%3ANDMA&limit=30
agreement
match
explanation
Queried fda.searchDrugRecalls('reason_for_recall:NDMA') live and filtered the 137 results client-side for product_description containing "metformin" — found 10 distinct metformin extended-release recall records in this single page alone (Teva Pharmaceuticals USA D-1331-2020; Marksans Pharma Limited D-1356-2020; Amneal Pharmaceuticals of New York, LLC D-1349-2020; Marksans Pharma Limited D-0061-2021; Nostrum Laboratories Inc D-0249-2021; Lupin Pharmaceuticals Inc. D-1382-2020; The Harvard Drug Group D-1360-2020; Amneal Pharmaceuticals of New York, LLC D-1348-2020; Amneal Pharmaceuticals of New York, LLC D-1351-2020; Preferred Pharmaceuticals, Inc. D-0077-2021), every one citing an NDMA-above-acceptable-limit finding — an exact match to the claimed mechanism and manufacturer list. CORRECTION (2026-07-12 adversarial audit): this explanation originally said each of the 10 records carried the quoted reason_for_recall text "verbatim" — re-running the identical live query shows only 6 of the 10 (Teva D-1331-2020, Marksans D-1356-2020, Amneal D-1349-2020/D-1348-2020/D-1351-2020, Lupin D-1382-2020) match that text word-for-word; the other 4 (Marksans D-0061-2021, Nostrum D-0249-2021, The Harvard Drug Group D-1360-2020, Preferred D-0077-2021) state the same NDMA-above-limit finding in variant wordings (e.g. "CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level"; "NDMA levels in excess of the Acceptable Daily Intake Limit"). The substance of the match is unchanged; the "verbatim for all 10" phrasing was an overstatement. LINK DRIFT (2026-07-13 adversarial audit): the originally-cited claim_source_url (fda.gov/.../laboratory-tests-fda-evaluate-ndma-levels-metformin) now returns HTTP 404 (FDA site reorganization); replaced with FDA's live "FDA Updates and Press Announcements on NDMA in Metformin" page, fetched 2026-07-13, which names Amneal (all lots), Marksans (labeled as Time-Cap), and Teva (labeled as Actavis, 14 lots) ER-metformin recalls for NDMA above the acceptable intake limit — the same claim support. All openFDA verified_value figures re-derived live 2026-07-13 and reproduced exactly (137 total NDMA records, same 10 metformin recall_numbers, same reason texts).
model_tested
claude-sonnet-5
model_question
Starting in mid-2020, why did several generic drug manufacturers recall specific lots of metformin hydrochloride extended-release tablets?
model_response
Several manufacturers (including Apotex, Amneal, Marksans, and others) recalled specific lots of extended-release metformin after FDA testing found levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake limit. This was part of a broader wave of NDMA contamination concerns that had earlier affected drugs like valsartan and ranitidine, and prompted the FDA to recommend testing and recall of affected metformin ER lots starting around May-June 2020.
model_verdict
correct
model_grading_note
Correctly identifies NDMA above acceptable intake limit as the cause; manufacturer list overlaps substantially with verified firms (Amneal, Marksans) with 'and others' covering the rest.
grading_mode
judge
difficulty
medium
tags
[
  "recall",
  "ndma",
  "metformin",
  "2020s"
]
Row 3 of 40
row_id
FDS03
claim
Beginning in 2018, valsartan-containing blood pressure medications were recalled by multiple manufacturers after nitrosamine impurities (NDMA/NDEA), traced to a change in the manufacturing process at a Chinese API supplier, were found in the active ingredient.
claim_source_url
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan
verification_method
openfda_drug_enforcement
verified_value
openFDA drug/enforcement.json search "valsartan" returns 137 live records; example D-0332-2019 (Mylan Laboratories Limited, (Nashik FDF)), reason_for_recall: "GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.", classification Class II.
verification_source_url
https://api.fda.gov/drug/enforcement.json?search=product_description%3A%22valsartan%22&limit=5
agreement
match
explanation
Called fda.searchDrugRecalls('valsartan') live: 137 total enforcement records. D-0332-2019 (Mylan Laboratories Limited, (Nashik FDF)) cites reason_for_recall "GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product." — NDEA, one of the two nitrosamine impurities named in the claim, confirmed verbatim in the live record. The valsartan recall wave is well known for eventually implicating multiple generic manufacturers sourcing API from the same supplier (Zhejiang Huahai Pharmaceutical); this endpoint records each manufacturer's own recall separately rather than one consolidated "valsartan recall" entity, consistent with openFDA's per-application recall structure.
model_tested
claude-sonnet-5
model_question
Beginning in 2018, why were valsartan-containing blood pressure medications recalled by multiple manufacturers, and what was the underlying source of the problem?
model_response
The 2018 valsartan recalls stemmed from contamination of the active pharmaceutical ingredient with nitrosamine impurities—primarily N-nitrosodimethylamine (NDMA) and later N-nitrosodiethylamine (NDEA)—which are probable human carcinogens. The contamination originated at certain generic API manufacturers, most notably China-based Zhejiang Huahai Pharmaceutical, where changes to the manufacturing process (involving solvents/reagents like dimethylformamide used with sodium nitrite) inadvertently generated these nitrosamine byproducts, which then ended up in valsartan supplied to numerous generic drug makers worldwide.
model_verdict
correct
model_grading_note
Matches verified NDMA/NDEA mechanism and Zhejiang Huahai Chinese API supplier source.
grading_mode
judge
difficulty
medium
tags
[
  "recall",
  "nitrosamine",
  "valsartan",
  "supply-chain"
]
Row 4 of 40
row_id
FDS04
claim
In February 2023, EzriCare and Delsam Pharma Artificial Tears (manufactured by Global Pharma Healthcare, India) were recalled after CDC/FDA linked them to a multistate outbreak of extensively drug-resistant Pseudomonas aeruginosa infections, including deaths and vision loss.
claim_source_url
https://www.fda.gov/drugs/drug-alerts-and-statements/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination
verification_method
openfda_drug_enforcement
verified_value
openFDA drug/enforcement.json confirms 2 EzriCare recall records; D-0919-2023 is classification Class I, reason_for_recall: "Non-Sterility: FDA analysis found unopened products to have bacterial contamination.", recall_initiation_date 20230130.
verification_source_url
https://api.fda.gov/drug/enforcement.json?search=product_description%3A%22EzriCare%22&limit=5
agreement
match
explanation
fda.searchDrugRecalls('EzriCare') returned 2 live records, including D-0919-2023 (Class I — FDA's most severe hazard classification) with reason_for_recall "Non-Sterility: FDA analysis found unopened products to have bacterial contamination." (non-sterility/bacterial contamination), consistent with the CDC's separately reported VIM-GES-CRPA outbreak (81+ patients across 18 states, 4 deaths, cases of vision loss and enucleation per CDC's own May 2023 update — CDC data, not openFDA, but cross-checked as the claim's causal-outcome half). The recall's own reason_for_recall field only records the contamination finding itself, not casualty counts — those come from the separate CDC HAI outbreak page, cited here as a second, independent public-health source rather than folded into the FDA enforcement record.
model_tested
claude-sonnet-5
model_question
What health issue was linked to EzriCare and Delsam Pharma Artificial Tears eye drops (made by Global Pharma Healthcare) that were recalled in February 2023?
model_response
These recalled eye drops were linked to a multi-state outbreak of drug-resistant Pseudomonas aeruginosa infections (a strain resistant to nearly all antibiotics), which caused serious harm including vision loss, bloodstream infections, and several deaths across the United States.
model_verdict
correct
model_grading_note
Correctly identifies drug-resistant Pseudomonas aeruginosa outbreak with deaths and vision loss, matching CDC data referenced in the record.
grading_mode
judge
difficulty
easy
tags
[
  "recall",
  "outbreak",
  "eye-drops",
  "2020s"
]
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