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Drug recall · FDA · Published July 18, 2019

Amneal Pharmaceuticals, Inc. recalls Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

Amneal recalls Methylergonovine Maleate 0.2mg tablets due to foreign promethazine tablets found in some bottles. This could cause unintended medication effects if taken.

🇺🇸 FDA recall #D-1516-2019DrugAmneal ›
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Contact the company & request your remedy

Recalling firmAmneal Pharmaceuticals, Inc.50 Horseblock Rd, N/A · Brookhaven, NY 11719-9509
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Amneal is recalling certain Methylergonovine Maleate tablets because a foreign promethazine tablet was found inside some bottles. This could lead to unintended medication effects if someone takes the foreign tablet. Read more at govinfonow.com/recall/38265-amneal-methylergonovine-tablets-recall-foreign-promethazine-tablet-found.

Source Summary by GovInfoNow · govinfonow.com/recall/38265-amneal-methylergonovine-tablets-recall-foreign-promethazine-tablet-found · Updated October 5, 2026 · FDA enforcement record: FDA #D-1516-2019

Cite this page

“Amneal Methylergonovine Tablets Recall: Foreign Promethazine Tablet Found.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38265-amneal-methylergonovine-tablets-recall-foreign-promethazine-tablet-found. Based on FDA recall #D-1516-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1516-2019%22&limit=1).

Why it’s dangerous

The recall is due to a foreign promethazine tablet being found inside some bottles of Methylergonovine Maleate tablets. If someone takes the foreign promethazine tablet, it could cause unintended medication effects.

Who’s affected

People who own or use the recalled Methylergonovine Maleate tablets (12-count or 28-count bottles with specific NDC numbers) are affected. Those most at risk are individuals taking the medication for medical conditions like postpartum hemorrhage.

How to tell if you have this one

Check for the 12-count (NDC 69238-1605-02) or 28-count (NDC 69238-1605-08) bottles with lot numbers BA10619A or BA10619B that expire by July 2020.

  • Brand
    Amneal
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Bottles

    Look for the 12-count (NDC 69238-1605-02) or 28-count (NDC 69238-1605-08) bottles with lot numbers BA10619A or BA10619B that expire by July 2020.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

Amneal found a foreign promethazine tablet in some bottles of Methylergonovine Maleate tablets, which could cause unintended medication effects if taken.

What should I do if I have the recalled product?

The official recall notice does not specify a remedy or action steps beyond checking your bottles for the recalled lot numbers.

Is there a risk of serious injury from this product?

The recall states a foreign tablet was found, but the official notice does not describe a risk of serious injury or death.

Take action

Contact Amneal

We’ve drafted a message you can send Amneal to request your refund or repair — edit it as you like.

Subject: Recall D-1516-2019 — Amneal Amneal

Hello,

I own a Amneal that is covered by recall D-1516-2019 from Amneal.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1516-2019 (July 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1516-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA