FDA drug recalls · openFDA

Is PRAVASTATIN SODIUM recalled?

The FDA has recorded 9 recalls of PRAVASTATIN SODIUM (2023–2025) , recalled under brand like PRAVASTATIN SODIUM. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of PRAVASTATIN SODIUM ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

CGMP Deviations 4

CGMP Deviations: recalling drug products following an FDA inspection. 4

Failed Dissolution Specifications: results below specifications 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx On Class II ongoing

Glenmark Pharmaceuticals Inc., USA 2025-03-13 lots: Lot # 17221770, exp. date Aug-25 17221774, exp. date Aug-25 17231251, exp. date May-26 17231262, exp. date May-26 17232112, exp. date Sep-26 17232133, exp. date Sep-26

Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx o Class II ongoing

Glenmark Pharmaceuticals Inc., USA 2025-03-13 lots: 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

Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by Class II ongoing

Glenmark Pharmaceuticals Inc., USA 2025-03-13 lots: Lot # 17230810, exp. date Mar-26

Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Class II ongoing

Glenmark Pharmaceuticals Inc., USA 2025-03-13 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

Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-1 Class II ongoing

Glenmark Pharmaceuticals Inc., USA 2024-06-28 lots: Lot#: a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290, 6/30/2024

Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC Class II Terminated

Accord Healthcare, Inc. 2023-02-07 lots: Batches: R2201233, Exp. Date 4/30/2024

Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC Class II Terminated

Accord Healthcare, Inc. 2023-02-07 lots: Batches: R2201294, Exp. Date 8/31/2025

Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b Class II Terminated

Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) R2201093, Exp. Date 4/30/2024; b) R2201222, R2201231, Exp. Date 4/30/2024;

Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27 Class II Terminated

Accord Healthcare, Inc. 2023-02-07 lots: Batches: a )R2200589, R2200689, R2200690, R2201232, Exp. Date 4/30/2024

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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