Pravastatin Sodium Tablets (Glenmark) – CGMP Deviations (2025)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
Brand
Glenmark Pharmaceuticals Inc., USA
Lot Codes / Batch Numbers
Lot # 17230810, exp. date Mar-26 17230811, exp. date Mar-26 17230810, exp. date Mar-26 17232501, exp. date Nov-26 17232502, exp. date Nov-26
Products Sold
Lot # 17230810, exp. date Mar-26 17230811, exp. date Mar-26 17230810, exp. date Mar-26 17232501, exp. date Nov-26 17232502, exp. date Nov-26
Glenmark Pharmaceuticals Inc., USA is recalling Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# due to CGMP Deviations. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026