Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross-contamination caused by cleaning failures.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or fatalities, and the hazard is a manufacturing deviation (cross-contamination) rather than a known high-risk pathogen or structural defect, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.25 mg, 90-count bottles. The recall involves 215,760 bottles distributed nationwide in the USA. The product is manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically cross-contamination with other products resulting from a cleaning failure. The affected lots include M706802, M706804, M706907, M706909, M707028, M714180, M714181, M717063, M717064, M801705, M801706, M801707, M801708, M714923, M714924, M714925, M808307, M808308, M808309, M808310, M812479, M812481, M812482, M812483, M815787, M815789, M815790, M815791, M815788, M820266, M820267, M820268, M820269, M820265, M903040, M903041, and M903042.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or supplier for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they are currently using the recalled medication.
The recalled product
- Product
- Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lots: M706802
- M706804
- M706907
- M706909
- M707028
- EXP May-19
- M714180
- M714181
- EXP Oct-19
- M717063
- M717064
- M801705
- M801706
- M801707
- M801708
- M714923
- M714924
- M714925 EXP Dec-19
- M808307
- M808308
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Zydus Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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