CLASS III Drug recall · Reported 31 Jul 2019 · FDA Enforcement Report
Methylergonovine Maleate recalled by Amneal Pharmaceuticals
Amneal Pharmaceuticals is recalling Methylergonovine Maleate USP 0, distributed nationwide in the US. The recall was initiated on 18 Jul 2019 and the FDA has classified it as Class III.
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-1516-2019
- FDA event ID
- 83206
- Recalling firm
- Amneal Pharmaceuticals, Brookhaven, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Jul 2019
- FDA classified
- 24 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 18 Jul 2019 | Recall initiated by company | |
| 24 Jul 2019 | Classified by FDA | +6 days |
| 31 Jul 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Product as listed by the FDA
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Where it was distributed
Product was distributed to three major distributors who may have further distributed the product nationwide.
Questions about this recall
Why was it recalled?
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Which lots are affected?
a) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020
Where was it sold?
Product was distributed to three major distributors who may have further distributed the product 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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|---|---|---|---|---|---|
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