Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross Contamination
Zydus Pharmaceuticals USA Inc is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross contamination caused by a cleaning failure.
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 is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is a manufacturing deviation (cross-contamination) rather than a known high-risk pathogen or structural defect.
Plain-English summary
Zydus Pharmaceuticals USA Inc is recalling Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottles, prescription only. The recall involves 3,156 bottles distributed nationwide in the USA.
The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically cross contamination with other products resulting from a cleaning failure. The affected lots are M706803 (EXP Jun-19), M713438 (EXP Oct-19), M801704 (EXP Jan-20), M808306 (EXP Jun-20), M812484 (EXP Aug-20), and M820264 (EXP Dec-20).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
- 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 (12)
- Lots: M706803
- EXP Jun-19
- M713438
- EXP Oct-19
- M801704
- EXP Jan-20
- M808306
- EXP Jun-20
- M812484
- EXP Aug-20
- M820264
- EXP Dec-20
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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