Prochlorperazine Maleate Tablets Recalled for Manufacturing Process Deviations
Glenmark Pharmaceuticals is voluntarily recalling Prochlorperazine Maleate 10mg tablets (NDC# 68462-890-01) distributed nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.
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: FDA Class II voluntary recall initiated by the manufacturer for CGMP deviations with no reported illnesses or injuries, fitting the rubric criterion for a precautionary recall at Moderate severity.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Prochlorperazine Maleate Tablets 10mg (100-count bottles) distributed nationwide. The affected product carries NDC# 68462-890-01 and was manufactured at Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India. Two lot numbers are affected: Lot #17240254 and Lot #17240257, both with January 2026 expiration dates.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. No illnesses or injuries have been reported.
This FDA Class II recall affects Prochlorperazine Maleate 10mg tablets distributed throughout the United States. Consumers with affected products should consult their healthcare provider or pharmacist for guidance. Pharmacists and healthcare facilities should return recalled products to the manufacturer or their pharmaceutical distributor. The recall was initiated on March 13, 2025.
The recalled product
- Product
- Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- manufacturing-process-deviation
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 (3)
- Lot # 17240254
- exp. date Jan-26 17240257
- exp. date Jan-26
Distribution
Distributed nationwide across the United States.
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