Recalls / Class II

Class IID-0338-2025

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

Affected lot / code info

Lot # 17240254, exp. date Jan-26 17240257, exp. date Jan-26

Why it was recalled

CGMP Deviations

Recalling firm

Firm

Glenmark Pharmaceuticals Inc., USA

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009

Distribution

Quantity

N/A

Distribution pattern

U.S. Nationwide

Timeline

Recall initiated

2025-03-13

FDA classified

2025-04-08

Posted by FDA

2025-04-16

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0338-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.