Key facts
| Recalling firm | ANI Pharmaceuticals, Inc. |
|---|---|
| Manufacturer | ANI Pharmaceuticals, Inc. |
| Brand name | ESTRADIOL |
| Product description | 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 |
| Classification | Class II |
| Recall number | D-0543-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Defective Container; packets were found to be either empty or partially full. |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is ANI Pharmaceuticals, Inc. and the affected product is described in FDA's record as: 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. FDA's stated reason for the recall is: Defective Container; packets were found to be either empty or partially full.. The recall is tracked under FDA recall number D-0543-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 -- and the recall number D-0543-2026. If it matches, stop using or distributing it and contact ANI Pharmaceuticals, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
ANI Pharmaceuticals, Inc.’s FDA history
Argus HQ has recorded 2 total FDA actions tied to ANI Pharmaceuticals, Inc.: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What was recalled and why?
- ANI Pharmaceuticals, Inc. recalled 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. FDA's record states the reason for recall as: Defective Container; packets were found to be either empty or partially full.. The recall is logged under FDA recall number D-0543-2026 with a Class II classification.
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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) and recall number D-0543-2026, then follow ANI Pharmaceuticals, Inc.'s recall instructions.
- Has ANI Pharmaceuticals, Inc. had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 2 total FDA actions tied to ANI Pharmaceuticals, Inc., including 2 recalls and 0 warning letters.
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Related enforcement actions
Full FDA history for ANI Pharmaceuticals, Inc.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class II Recall: ESTRADIOL by ANI Pharmaceuticals, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-ani-pharmaceuticals-inc-d-0543-2026
"FDA Recall Database: Class II Recall: ESTRADIOL by ANI Pharmaceuticals, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-ani-pharmaceuticals-inc-d-0543-2026.
Argus HQ Research. "FDA Recall Database: Class II Recall: ESTRADIOL by ANI Pharmaceuticals, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-ani-pharmaceuticals-inc-d-0543-2026.
@misc{argushq_argushq_ai_recall_fda_recall_ani_pharmaceuticals_inc_d_0543_2026_2026,
title = {FDA Recall Database: Class II Recall: ESTRADIOL by ANI Pharmaceuticals, Inc.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-ani-pharmaceuticals-inc-d-0543-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗