CLASS III Drug recall · Reported 9 Dec 2015 · FDA Enforcement Report
Prednisone 20 mg, Tablet recalled by Northwind Pharmaceuticals
Northwind Pharmaceuticals is recalling Prednisone 20 mg, Tablet, distributed nationwide in the US. The recall was initiated on 10 Nov 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0485-2016
- FDA event ID
- 72647
- Recalling firm
- Northwind Pharmaceuticals, Indianapolis, IN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Nov 2015
- FDA classified
- 2 Dec 2015
- Reported
- 9 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
Timeline
| 10 Nov 2015 | Recall initiated by company | |
| 2 Dec 2015 | Classified by FDA | +22 days |
| 9 Dec 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Which lots are affected?
Lot # NW 46400021, Exp 03/2018
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Northwind Pharmaceuticals
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim | Northwind Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Glimepiride Tablets, USP 4mg recalled by Northwind PharmaceuticalsGlimepiride | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tadalafil Tablets, USP 5 mg recalled by Northwind PharmaceuticalsTadalafil | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Doxazosin Tablets, USP, 4mg recalled by Northwind PharmaceuticalsDoxazosin | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets, USP, 10 mg recalledAtorvastatin Calcium | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Prednisone recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PredniSONE Tablets, USP, 20 mg recalled by Cardinal Healthcare | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prednisone Tablets USP, 20 mg recalled by Strides PharmaPrednisone | Strides Pharma | Other | Nationwide |
| Drug | CLASS II | Prednisone Tablets, USP 2.5 mg recalled by Lannett Company | Lannett | Other | Nationwide |
| Drug | CLASS III | PrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisone | Par Pharmaceutical | Other | Nationwide |
| Drug | CLASS II | PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone | West-Ward Pharmaceutical | Other | Nationwide |