Northwind Pharmaceuticals LLC

Complete recall history across all FDA and CPSC categories — 13 total recalls

Northwind Pharmaceuticals LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (13)

FDA drug safety enforcement actions by Northwind Pharmaceuticals LLC

Date Product Reason Class
Aug 20, 2025 Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength ... Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, ... Class II
Mar 16, 2023 Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-... CGMP Deviations Class II
Mar 16, 2023 Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northw... CGMP Deviations Class II
Mar 16, 2023 Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northw... CGMP Deviations Class II
Mar 16, 2023 Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackag... CGMP Deviations Class II
Mar 16, 2023 Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-... CGMP Deviations Class II
Mar 16, 2023 BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repac... CGMP Deviations Class II
Mar 16, 2023 Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-8... CGMP Deviations Class II
Jul 18, 2018 Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind P... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... Class II
Jul 18, 2018 Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pha... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... Class II
Jul 18, 2018 Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Ph... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... Class II
Jul 18, 2018 Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: No... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... Class II
Nov 10, 2015 Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti... Labeling: Not elsewhere classified. NDC number is incorrect on the container. Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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