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Class IIOngoing

Pravastatin Sodium Tablets 80mg recall

FDA recall D-0325-2025 · initiated Mar 13, 2025

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Apr 16, 2025How we research

Glenmark Pharmaceuticals Inc., USA recalled Pravastatin Sodium Tablets 80mg in Mar 2025 — an FDA Class II recall (D-0325-2025) because CGMP Deviations.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations

The manufacturing process itself

The FDA found the process itself out of compliance, usually before any defective product was identified.

This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.

Is your product affected? Check the lot number

A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.

Lot # 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-26

Quantity recalled: N/A

Details

Product
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.
Recalling company
Glenmark Pharms
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
U.S. Nationwide
Initiated
Mar 13, 2025
FDA report date
Apr 16, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was Pravastatin Sodium Tablets 80mg recalled?
Glenmark Pharmaceuticals Inc., USA recalled Pravastatin Sodium Tablets 80mg in Mar 2025 — an FDA Class II recall (D-0325-2025) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
Why was Pravastatin Sodium Tablets 80mg recalled?
Per the FDA enforcement record, the reason for recall D-0325-2025 was: CGMP Deviations
Is a recalled Pravastatin Sodium Tablets 80mg dangerous to take?
An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
Which lots of Pravastatin Sodium Tablets 80mg are affected?
Distributed: U.S. Nationwide. The recall covers these lots — Lot # 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-26. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0325-2025.

Source: openFDA Drug Enforcement record D-0325-2025 ↗

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