Estradiol Gel recall
FDA recall D-0543-2026 · initiated May 12, 2026
ANI Pharmaceuticals, Inc. recalled Estradiol Gel in May 2026 — an FDA Class II recall (D-0543-2026) because Defective Container; packets were found to be either empty or partially full.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Container; packets were found to be either empty or partially full.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3964 Cartons
Details
- Product
- 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
- Recalling company
- Ani Pharms Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 12, 2026
- FDA report date
- May 27, 2026
Frequently asked
- Was Estradiol Gel recalled?
- ANI Pharmaceuticals, Inc. recalled Estradiol Gel in May 2026 — an FDA Class II recall (D-0543-2026) because Defective Container; packets were found to be either empty or partially full. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Estradiol Gel recalled?
- Per the FDA enforcement record, the reason for recall D-0543-2026 was: Defective Container; packets were found to be either empty or partially full.
- Is a recalled Estradiol Gel dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Estradiol Gel are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot M251109, exp Nov 2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0543-2026.