Pramipexole ER Tablets (Par) – impurity concern (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse 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
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
Brand
Par Pharmaceutical, Inc.
Lot Codes / Batch Numbers
Lot #: 29906202, Exp 12/18, 29993102, Exp 2/19, 30366102, 30373103, Exp 4/19, 31940601, Exp 3/20.
Products Sold
Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.
Par Pharmaceutical, Inc. is recalling Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only due to Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.. 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
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
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