ANI Pharmaceuticals recalls

ANI Pharmaceuticals has 13 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 1 Jul 2026. 2 are still ongoing. 2 were reported in the last 12 months.

Total recalls13since 2020

Last 12 months2reported

Class I00% of total

Ongoing2latest 1 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 0 1Jul 0 0

Severity split

Class I 0 0%Class II 6 46%Class III 7 54%

Why ani pharmaceuticals is recalled

Other Reasons862%
Manufacturing (CGMP) Deviations538%

Product types

Brands

By year

2026215%
2022538%
2020646%

Ongoing ani pharmaceuticals recalls

2 active

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS III	hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride	ANI Pharmaceuticals	Other	Nationwide
27 May 2026Drug	CLASS II	Estradiol Gel, 1%, 25 mg per packet, 30 packets recalledEstradiol	ANI Pharmaceuticals	Other	Nationwide

All ani pharmaceuticals recalls, newest first

13 total

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS III	hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride	ANI Pharmaceuticals	Other	Nationwide
27 May 2026Drug	CLASS II	Estradiol Gel, 1%, 25 mg per packet, 30 packets recalledEstradiol	ANI Pharmaceuticals	Other	Nationwide
23 Feb 2022Drug	CLASS II	Alprazolam Tablets, USP 0 mg recalled by ANI Pharmaceuticals	ANI Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
23 Feb 2022Drug	CLASS II	Alprazolam Tablets, USP 0 mg recalled by ANI Pharmaceuticals	ANI Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
23 Feb 2022Drug	CLASS II	Pyrazinamide Tablets, USP 500 mg recalled by ANI Pharmaceuticals	ANI Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
23 Feb 2022Drug	CLASS II	Alprazolam Tablets, USP 25 mg recalled by ANI Pharmaceuticals	ANI Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
23 Feb 2022Drug	CLASS II	Alprazolam Tablets, USP 5 mg recalled by ANI Pharmaceuticals	ANI Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
28 Oct 2020Drug	CLASS III	Dextroamphetamine Saccharate recalled by ANI PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	ANI Pharmaceuticals	Other	Nationwide
28 Oct 2020Drug	CLASS III	Dextroamphetamine Saccharate recalled by ANI PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	ANI Pharmaceuticals	Other	Nationwide
28 Oct 2020Drug	CLASS III	Dextroamphetamine Saccharate recalled by ANI PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	ANI Pharmaceuticals	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.