Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.5 mg due to cross-contamination caused by a cleaning failure.
What this means for you
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottles, NDC 68382-198-16. The recall involves 168,330 bottles distributed nationwide in the USA.
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 M713431, M713432, M714172, M714173, M800552, M800553, M800554, M800555, M800556, M811135, M812818, M812819, M812820, M812821, M815777, M815778, M815779, M815780, M815781, M901927, M901929, M901931, M901933, and M902089, with expiration dates ranging from September 2019 to January 2021.
Patients and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Hazard
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 (13)
- Lots:M713431
- M713432
- M714172
- EXP Sep-19
- M714173
- Oct-19
- M800552
- M800553
- M800554
- M800555 M800556 EXP Dec-19
- M811135 M812818 M812819 M812820 M812821 EXP Jun-20
- M815777 M815778 M815779 M815780 M815781 EXP Aug-20
- M901927 M901929 M901931 M901933 M902089 EXP Jan-21
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.
See all 14 products in this recall →Related recalls
Same manufacturer · Zydus Pharmaceuticals USA Inc
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
Same hazard · cross contamination
See all →- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
- ModeratePrimidone tablets recalled over potential acemetacin cross-contamination at API manufacturer
FDA (Drugs) · 2026-06-17
- HighFly By Jing creamy sesame noodles may contain undeclared peanut
FDA (Food) · 2026-06-03
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets 50 mg Recalled for API Cross-Contamination
FDA (Drugs) · 2026-05-27