Quinacrine Dihydrochloride (Darmerica) - label mix-up (2019)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707
Brand
Darmerica, LLC
Lot Codes / Batch Numbers
Lot#: a) DL4654A, Exp. 04/27/21, b) DR4654, Exp. 04/27/21 c) DR4654, Exp. 04/27/21
Products Sold
Lot#: a) DL4654A, Exp. 04/27/21; b) DR4654, Exp. 04/27/21 c) DR4654, Exp. 04/27/21
Darmerica, LLC is recalling Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 due to Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026