CLASS II Drug recall · Reported 23 Jan 2013 · FDA Enforcement Report
Prednisone tablets, USP, 10mg recalled by L. Perrigo
L. Perrigo is recalling Prednisone tablets, USP, 10mg, distributed nationwide in the US. The recall was initiated on 17 Dec 2012 and the FDA has classified it as Class II.
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-125-2013
- FDA event ID
- 63966
- Recalling firm
- L. Perrigo, Allegan, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2012
- FDA classified
- 14 Jan 2013
- Reported
- 23 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
Timeline
| 17 Dec 2012 | Recall initiated by company | |
| 14 Jan 2013 | Classified by FDA | +28 days |
| 23 Jan 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
Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.
Where it was distributed
Nationwide
Questions about this recall
Is Prednisone tablets, USP, 10mg recalled?
Yes. L. Perrigo recalled Prednisone tablets, USP, 10mg on 17 Dec 2012. The recall is Class II and its status is Terminated. Recall number D-125-2013.
Why was it recalled?
Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Which lots are affected?
Lot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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 L. Perrigo
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|---|---|---|---|---|---|
| Drug | CLASS II | aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg recalledExchange Select Aller Ease | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy Aller-fex, Fexofenadine Hydrochloride Tablets, 180 mg recalledKirkland Signature Aller Fex | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride recalledBerkley Jensen Allergy Relief | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy, Fexofenadine Hydrochloride Tablets, 180 mg recalledBasic Care Allergy | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine recalled | L. Perrigo | Potency & Assay | Nationwide |
Other Prednisone recalls
All 9| 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 5 mg recalled by Lannett Company | Lannett Company | 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 |