Unrated Drug recall · FDA · Published September 6, 2019

Darmerica Quinacrine Dihydrochloride Product Mislabeled as Artemisinin

Darmerica recalls bulk Quinacrine Dihydrochloride API products that were mislabeled as Artemisinin. These products may be dangerous due to incorrect labeling.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0125-2020Drug Darmerica ›

Recall notice

Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.

Take action

Contact the company

Recalling firmDarmerica, LLC198 Wilshire Blvd · Casselberry, FL 32707-5352

✎ GovInfoNow plain-language explainer

Darmerica is recalling bulk Quinacrine Dihydrochloride products that were mislabeled as Artemisinin. This could be dangerous because Artemisinin is a different compound with potential health risks. Read more at govinfonow.com/recall/38023-darmerica-quinacrine-dihydrochloride-product-mislabeled-as-artemisinin.

Source Summary by GovInfoNow · govinfonow.com/recall/38023-darmerica-quinacrine-dihydrochloride-product-mislabeled-as-artemisinin · Updated October 5, 2026 · FDA enforcement record: FDA #D-0125-2020

Cite this page

“Darmerica Quinacrine Dihydrochloride Product Mislabeled as Artemisinin.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38023-darmerica-quinacrine-dihydrochloride-product-mislabeled-as-artemisinin. Based on FDA recall #D-0125-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0125-2020%22&limit=1).

The FDA announced on Sept. 6, 2019, that Darmerica LLC voluntarily recalled Quinacrine Dihydrochloride bulk API due to a label mix-up hazard. The product was mislabeled as Quinacrine Dihydrochloride but identified as Artemisinin after testing.

How to tell if you have it

Brand: Darmerica
Product: Quinacrine Dihydrochloride (98.25%), bulk API
Packaging: a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55; c) 25g NDC# 71052-530-25
Lot codes: a) DL4654A, Exp. 04/27/21; b) DR4654, Exp. 04/27/21; c) DR4654, Exp. 04/27/21
Distribution: U.S.A. Nationwide

The hazard

The product was labeled as Quinacrine Dihydrochloride but identified as Artemisinin after testing. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show other recent recalls of similar products include American Health Packaging Buprenorphine Tablets Recall (2026-08-19), American Regent Levocarnitine Injection Recall (2026-04-16), and Ajanta Pharma Aripiprazole Tablets 30mg (2026-05-27).

How to tell if you have this one

Check for the NDC numbers: 71052-530-05 (500g), 71052-530-55 (50g), or 71052-530-25 (25g). The products were manufactured by Darmerica LLC in Casselberry, Florida.

Brand
Darmerica
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Verify the product label matches the NDC numbers listed: 71052-530-05, 71052-530-55, or 71052-530-25.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Sep 6, 2019Firm started the recall
Oct 2, 2019Published in FDA’s Enforcement Report
Oct 3, 2019FDA classified it Class I
Feb 5, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/38023-darmerica-quinacrine-dihydrochloride-product-mislabeled-as-artemisinin">Darmerica Quinacrine Dihydrochloride Product Mislabeled as Artemisinin (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0125-2020 (September 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0125-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.