Class II · Moderate risk
Carton Label: MAJOR
Subpotent Drug
Methylergonovine Maleate Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Affected NDC
69238-1605-02
Compare with the code on your package — it is the most precise check available.
Drug: Methylergonovine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Methylergonovine Maleate Methylergonovine NDC 69238-1605 |
MALEATE .2 mg/1 | Tablet Oral |
Amneal Pharmaceuticals NY LLC | Rx |
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- NDC code
- 69238-1605-2
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0477-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Methylergonovine recalls
See all
Class III · Low risk
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Class II · Moderate risk
METHYLERGONOVINE MALEATE Tablet
Labeling: Label Mixup; METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD52778_31, EXP: 5/20/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003476, EXP: 6/20/2014.
Other recalls by Amneal Pharmaceuticals of New York, LLC
All 2024 recalls
Class II · Moderate risk
Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
Class I · High risk
Vancomycin Hydrochloride for Oral Solution
Superpotent Drug: Due to overfilling of drug powder
Class II · Moderate risk
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II · Moderate risk
Phenoxybenzamine Hydrochloride Capsules
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
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