Ergoloid Mesylates — Class II drug recall D-0414-2015
Terminated recall by Mutual Pharmaceutical Company, Inc., reported 2015-03-25, distributed nationwide. Failed Impurities/Degradation Specifications: during long-term stability testing.
| Recall number | D-0414-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mutual Pharmaceutical Company, Inc., Philadelphia, PA, United States |
| Recall initiated | 2015-03-10 |
| Classified | 2015-03-16 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 23,246 bottles |
| Reason classes | specification failure |
| NDC | 53489-0281-01 |
| Lot numbers | 10/16, 3/15, 4/17, 6557301, 6557401, 6557501, 6656301, 6687701 |
Product
Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01
Reason for recall
Failed Impurities/Degradation Specifications: during long-term stability testing.
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-0414-2015. 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.