Pramipexole Tablets 0.125mg (American Health) – Cross-Contamination Risk (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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
Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25
Brand
American Health Packaging
Lot Codes / Batch Numbers
Lot, expiry: Lot 179049, exp 12/31/2019, Lot 182571, exp 8/31/2020
Products Sold
Lot, expiry: Lot 179049, exp 12/31/2019; Lot 182571, exp 8/31/2020
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Dis due to GMP Deviations; possible cross contamination of product due to cleaning procedure failure.. 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
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
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