Pravastatin Sodium recalls: 13 FDA reports
Recalls involving Pravastatin Sodium. What was wrong with each batch, and how the FDA graded the risk.
13Reports
0Class I
5Ongoing
2025-04-16Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-
D-0350-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
- Where it went
- U.S. Nationwide
- How much
- N/A
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196
D-0341-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- CGMP Deviations
- 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.
- Where it went
- U.S. Nationwide
- How much
- N/A
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 381
D-0349-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01
- Where it went
- U.S. Nationwide
- How much
- N/A
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,
D-0325-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- CGMP Deviations
- 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.
- Where it went
- U.S. Nationwide
- How much
- N/A
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, N
D-0612-2024 · Class II · reported 2024-07-24 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications: results below specifications
- Product
- Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
- Where it went
- USA Nationwide
- How much
- a) 145,800 bottles; b) 1,368 bottles
Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., D
D-0424-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-011-15, UPC 3 16729 01115 0
- Where it went
- United States including Puerto Rico and Canada
- How much
- 1970 bottles
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc.,
D-0423-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-010-17, UPC 3 16729 01017 7
- Where it went
- United States including Puerto Rico and Canada
- How much
- 120 bottles
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729
D-0421-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Where it went
- United States including Puerto Rico and Canada
- How much
- 9600 bottles
Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Dur
D-0422-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009-15, UPC 3 16729 00915 7.
- Where it went
- United States including Puerto Rico and Canada
- How much
- 32,688 bottles
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Lt
D-1120-2019 · Class II · reported 2019-04-17 · Terminated
- Why it was recalled
- Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
- Product
- Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
- Where it went
- Nationwide in the USA
- How much
- 2076 500-count Bottles
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc
D-0092-2018 · Class II · reported 2017-11-29 · Terminated
- Why it was recalled
- Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
- Product
- Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09
- Where it went
- Product was distributed throughout the United States, including Puerto Rico.
- How much
- N/A
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bo
D-1038-2017 · Class III · reported 2017-08-09 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
- Product
- Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
- Where it went
- Nationwide in the USA
- How much
- 544 bottles
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenm
D-330-2013 · Class III · reported 2013-05-22 · Terminated
- Why it was recalled
- Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
- Product
- Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430
- Where it went
- Nationwide
- How much
- 246,528 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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