ANI Pharmaceuticals' product recalls
2 official recall notices between May 2026 and Jul 2026 were matched to ANI Pharmaceuticals.
Each notice concerns the specific products, sizes and lot codes it names. A recall does not mean that other ANI Pharmaceuticals products are affected, and a count of notices is not a measure of safety: one incident can produce a notice for every pack size.
Covers only notices from the U.S. Food and Drug Administration enforcement reports (openFDA), USDA Food Safety and Inspection Service recalls, UK Food Standards Agency food alerts and U.S. Consumer Product Safety Commission recalls that could be matched to ANI Pharmaceuticals: the recalling firm must be ANI Pharmaceuticals, a parent or a subsidiary, and for a brand the brand name must appear in the product description. Method.
2026 (2)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC:… | — | ANI Pharmaceuticals, Inc. | Presence of foreign substance Class III | 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 | — | ANI Pharmaceuticals, Inc. | Defective Container; packets were found to be either empty or partially full. Class II | FDA |
Product descriptions and reasons are shortened from the regulators' own text; the linked notice is the authoritative record. See all matched recalls, or report a wrong match through the corrections page.