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Northwind Pharmaceuticals LLC

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20151
20184
20237
20251
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FDA Recall Ongoing Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.

by Northwind Pharmaceuticals LLC

Reason
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Published
September 24, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Published
May 3, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Published
May 3, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Published
May 3, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Published
May 3, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Published
May 3, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Published
May 3, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Published
May 3, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published
August 22, 2018
Distribution
Indiana

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FDA Recall Terminated Historical recordClass II

Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published
August 22, 2018
Distribution
Indiana

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FDA Recall Terminated Historical recordClass II

Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published
August 22, 2018
Distribution
Indiana

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FDA Recall Terminated Historical recordClass II

Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published
August 22, 2018
Distribution
Indiana

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This page lists recalls that name Northwind Pharmaceuticals LLC as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.