Class II U.S. Food and Drug Administration

ANI Pharmaceuticals, Inc. Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet recall: Defective Container; packets were found to be either empty or partially full

Recall published 5 months ago

Defective Container; packets were found to be either empty or partially full.

The hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

What the notice says: Defective Container; packets were found to be either empty or partially full.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0543-2026
Published
May 27, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
ANI Pharmaceuticals, Inc.
Product type
Prescription & OTC drugs
Units affected
3964 Cartons
Distribution
Nationwide
Made in
United States
Lot / code info
Lot M251109, exp Nov 2027

Products covered by this recall

Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • M251109

NDC number

On the carton and again on the bottle or blister label.

  • 70954-531-20

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.25 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

ANI Pharmaceuticals, Inc. — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: ANI Pharmaceuticals, Inc. — 210 W Main St, Baudette, MN, 56623-2467

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was ANI Pharmaceuticals, Inc. prescription & otc drugs recalled?

Defective Container; packets were found to be either empty or partially full. Defective Container; packets were found to be either empty or partially full.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code M251109. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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