CLASS II Drug recall · Reported 8 May 2024 · FDA Enforcement Report
Methylergonovine Maleate Tablets, USP, 0.2mg recalled
Amneal Pharmaceuticals of New York is recalling Methylergonovine Maleate Tablets, USP, 0.2mg, distributed nationwide in the US. The recall was initiated on 25 Mar 2024 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-0477-2024
- FDA event ID
- 94286
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 25 Mar 2024
- FDA classified
- 29 Apr 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 25 Mar 2024 | Recall initiated by company | |
| 29 Apr 2024 | Classified by FDA | +35 days |
| 8 May 2024 | 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 Dissolution Specifications
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
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: BJ01922A, exp. date 03/2024
Where was it sold?
US 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 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 Amneal Pharmaceuticals of New York
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
Other Methylergonovine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Methylergonovine Maleate Tablet, 0.2 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |