PredniSONE Tablets — Class II drug recall D-133-2013
Terminated recall by West-ward Pharmaceutical Corp., reported 2013-01-30, distributed nationwide. Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusi
| Recall number | D-133-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-ward Pharmaceutical Corp., Eatontown, NJ, United States |
| Recall initiated | 2012-12-05 |
| Classified | 2013-01-18 |
| Reported by FDA | 2013-01-30 |
| Terminated | 2014-05-16 |
| Distributed | Nationwide (US) |
| Quantity | 60,289 bottles |
| NDC | 00143-1477-01, 00143-1477-05, 00143-1477-10 |
| Lot numbers | 01/15, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68581A, 68581B, 68582A, 68582B |
Product
PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
Reason for recall
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-133-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.