Pramipexole Tablets (Zydus) – 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 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
Brand
Zydus Pharmaceuticals USA Inc
Lot Codes / Batch Numbers
Lots: M714186 M714187 M714188 EXP Oct-19, M714903 M714904 M714905 M715586 M715587 EXP Nov-19, M801441 M801442 M801443 M801444 M801445 EXP Dec-19, M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20, M814299 M814300 M814301 M814302 EXP Aug-20, M818136 M818137 M818138 M818139 M818140 EXP Nov-20
Products Sold
Lots: M714186 M714187 M714188 EXP Oct-19; M714903 M714904 M714905 M715586 M715587 EXP Nov-19; M801441 M801442 M801443 M801444 M801445 EXP Dec-19; M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20; M814299 M814300 M814301 M814302 EXP Aug-20; M818136 M818137 M818138 M818139 M818140 EXP Nov-20
Zydus Pharmaceuticals USA Inc is recalling Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthca due to CGMP Deviations: Cross Contamination with other products due to CGMP cleaning 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
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning 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