Class III · Lower riskRecall completed
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numbera) Lot # BA10619A, b) Lot # BA10619B, exp. date 07/2020
Where it was soldProduct was distributed to three major distributors who may have further distributed the product nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Amneal Pharmaceuticals, Inc. |
| NDC | 69238-1605-02 |
Show the full FDA record
| Full product label | Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08) |
| Recalling firm | Amneal Pharmaceuticals, Inc. |
| Distribution | Product was distributed to three major distributors who may have further distributed the product nationwide. |
| Quantity | a) 2,256 bottles; b) 240 bottles |
| Recall initiated | 2019-07-18 |
| Report date | 2019-07-31 |
| Recall completed | 2020-04-22 |
| Recall number | D-1516-2019 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Brookhaven NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.