CLASS III Drug recall · Reported 21 Aug 2013 · FDA Enforcement Report
Prednisone Tablet recalled by Boehringer Ingelheim Roxane
Boehringer Ingelheim Roxane is recalling Prednisone Tablet USP, distributed nationwide in the US. The recall was initiated on 14 Jun 2013 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-882-2013
- FDA event ID
- 65467
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Brand
- Prednisone
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Jun 2013
- FDA classified
- 12 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
Timeline
| 14 Jun 2013 | Recall initiated by company | |
| 12 Aug 2013 | Classified by FDA | +59 days |
| 21 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing Label; missing label on blister card
Product as listed by the FDA
Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Missing Label; missing label on blister card
Which lots are affected?
The affected product consists of lot #261739A, expiration date OCT 2014.
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 Boehringer Ingelheim Roxane
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Combivent Respimat (ipratropium bromide recalledCombivent Respimat | Boehringer Ingelheim Roxane | Other | Nationwide |
| Drug | CLASS II | Acarbose Tablets 50 mg a) Unit Dose Tablets per, b) recalledAcarbose | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial recalled | Boehringer Ingelheim Roxane | Potency & Assay | 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 |