Northwind Pharmaceuticals recalls
Northwind Pharmaceuticals appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2025-09-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2015-12-09 to 2025-09-24 |
| By agency | FDA Drug (13) |
| By classification | Class II (12), Class III (1) |
| By status | ongoing (8), terminated (5) |
| Distribution named in notices | IN, US |
Recalls
- Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count…
FDA Drug · Class II · 2025-09-24 · Northwind Pharmaceuticals
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 d… - 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, Repac…
FDA Drug · Class II · 2023-05-03 · Northwind Pharmaceuticals
Reason: CGMP Deviations - Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203
FDA Drug · Class II · 2023-05-03 · Northwind Pharmaceuticals
Reason: CGMP Deviations - 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, Repa…
FDA Drug · Class II · 2023-05-03 · Northwind Pharmaceuticals
Reason: CGMP Deviations - 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, Repac…
FDA Drug · Class II · 2023-05-03 · Northwind Pharmaceuticals
Reason: CGMP Deviations - Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203
FDA Drug · Class II · 2023-05-03 · Northwind Pharmaceuticals
Reason: CGMP Deviations - Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203
FDA Drug · Class II · 2023-05-03 · Northwind Pharmaceuticals
Reason: CGMP Deviations - BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203
FDA Drug · Class II · 2023-05-03 · Northwind Pharmaceuticals
Reason: CGMP Deviations - Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
FDA Drug · Class II · 2018-08-22 · Northwind Pharmaceuticals
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
FDA Drug · Class II · 2018-08-22 · Northwind Pharmaceuticals
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
FDA Drug · Class II · 2018-08-22 · Northwind Pharmaceuticals
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
FDA Drug · Class II · 2018-08-22 · Northwind Pharmaceuticals
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan
FDA Drug · Class III · 2015-12-09 · Northwind Pharmaceuticals
Reason: Labeling: Not elsewhere classified. NDC number is incorrect on the container.