CLASS II Drug recall · Reported 25 Mar 2015 · FDA Enforcement Report
Ergoloid Mesylates recalled by Mutual Pharmaceutical Company
Mutual Pharmaceutical Company is recalling Ergoloid Mesylates, distributed nationwide in the US. The recall was initiated on 10 Mar 2015 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-0414-2015
- FDA event ID
- 70711
- Recalling firm
- Mutual Pharmaceutical Company, Philadelphia, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2015
- FDA classified
- 16 Mar 2015
- Reported
- 25 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 10 Mar 2015 | Recall initiated by company | |
| 16 Mar 2015 | Classified by FDA | +6 days |
| 25 Mar 2015 | 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
Failed Impurities/Degradation Specifications: during long-term stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Ergoloid Mesylates recalled?
Yes. Mutual Pharmaceutical Company recalled Ergoloid Mesylates on 10 Mar 2015. The recall is Class II and its status is Terminated. Recall number D-0414-2015.
Why was it recalled?
Failed Impurities/Degradation Specifications: during long-term stability testing.
Which lots are affected?
Lot #: 6557301, Exp 3/15; 6557401, Exp 3/15; 6557501, Exp 3/15; 6656301, Exp 10/16; 6687701, Exp 4/17.
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 Mutual Pharmaceutical Company
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalled | Mutual Pharmaceutical Company | Other | MS |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 10 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 25 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 50 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |
| Drug | CLASS III | Felodipine Extended-Release Tablets, 5 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |