AvKARE recalls

AvKARE has 62 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 4 Mar 2026. 22 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls62since 2015

Last 12 months3reported

Class I23% of total

Ongoing22latest 4 Mar 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 5 3 2Feb 0 0 0May 2 2 0Aug 2 1 0Nov 0 1 0Feb 1 0 0May 0 0 0Aug 0 0

Severity split

Class I 2 3%Class II 47 76%Class III 13 21%

Why avkare is recalled

Product types

Brands

By year

202623%
20251219%
2024610%
202346%
202212%
202112%
2020711%
20191219%
20181219%
201735%

Ongoing avkare recalls

22 active

Reported	Class	Recall	Company	Reason	Where
4 Mar 2026Drug	CLASS II	Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl	AvKARE	Potency & Assay	Nationwide
14 Jan 2026Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin	AvKARE	Potency & Assay	Nationwide
15 Oct 2025Drug	CLASS II	Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 2 mg recalled by AvKAREPitavastatin	AvKARE	Potency & Assay	Nationwide

All avkare recalls, newest first

62 total

Reported	Class	Recall	Company	Reason	Where
4 Mar 2026Drug	CLASS II	Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl	AvKARE	Potency & Assay	Nationwide
14 Jan 2026Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin	AvKARE	Potency & Assay	Nationwide
15 Oct 2025Drug	CLASS II	Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 2 mg recalled by AvKAREPitavastatin	AvKARE	Potency & Assay	Nationwide
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 1 mg recalled by AvKAREPitavastatin	AvKARE	Potency & Assay	Nationwide
18 Jun 2025Drug	CLASS II	Celecoxib Capsules, 200 mg Unit Dose recalled by AvKARECelecoxib	AvKARE	Hidden Drug Ingredients	Nationwide
18 Jun 2025Drug	CLASS II	Chlorthalidone Tablets, USP, 25 mg Unit Dose cards recalled by AvKAREChlorthalidone	AvKARE	Potency & Assay	Nationwide
26 Feb 2025Drug	CLASS II	Silodosin Capsules, 8mg recalled by AvKARESilodosin	AvKARE	Potency & Assay	Nationwide
19 Feb 2025Drug	CLASS II	Irbesartan Tablets USP, 300 mg Dose recalled by AvKARE	AvKARE	Potency & Assay	Nationwide
8 Jan 2025Drug	CLASS III	Polyvinyl Alcohol Ophthalmic Solution recalled by AvKAREPolyvinyl Alcohol	AvKARE	Packaging Defects	Nationwide
8 Jan 2025Drug	CLASS II	Nitrofurantoin Capsules, USP, 100 mg Dose recalled by AvKARE	AvKARE	Potency & Assay	Nationwide
8 Jan 2025Drug	CLASS III	Carboxymethylcellulose Sodium Ophthalmic Solution recalled by AvKARECarboxymethylcellulose Sodium	AvKARE	Packaging Defects	Nationwide
11 Dec 2024Drug	CLASS II	Sunitinib Malate Capsules, 25 mg recalled by AvKARESunitinib Malate	AvKARE	Packaging Defects	Nationwide
11 Dec 2024Drug	CLASS II	Cinacalcet Tablets, 30 mg recalled by AvKARE	AvKARE	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Cinacalcet Tablets, 90 mg recalled by AvKARE	AvKARE	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Cinacalcet Tablets, 60 mg recalled by AvKARE	AvKARE	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Sunitinib Malate Capsules, 12.5 mg recalled by AvKARESunitinib Malate	AvKARE	Packaging Defects	Nationwide
24 Apr 2024Drug	CLASS I	Atovaquone Oral Suspension USP, 750 mg per sachets recalled by AvKARE	AvKARE	Other Bacterial Contamination	Nationwide
13 Sep 2023Drug	CLASS II	Sodium Fluoride 1.1%, Sodium Fluoride Prescription Dental recalledSodium Flouride	Avkare	Other	TN
13 Sep 2023Drug	CLASS II	Capsaicin Cream 0.025%, External Analgesic Cream recalled by AVKARECapsaicin	Avkare	Packaging Defects	TN
21 Jun 2023Drug	CLASS III	Tranexamic Acid USP Tablets, 650 mg Unit Dose recalled by AVKARETranexamic Acid	Avkare	Potency & Assay	Nationwide
4 Jan 2023Drug	CLASS II	Glycopyrrolate Tablets, USP, 1 mg Unit Dose recalled by AVKAREGlycopyrrolate	Avkare	Potency & Assay	Nationwide
17 Aug 2022Drug	CLASS III	Lamotrigine Tablets, USP 100 mg recalled by AVKARELamotrigine	Avkare	Other	Nationwide
23 Jun 2021Drug	CLASS III	Phytonadione Tablets 5 mg recalled by AVKARE	Avkare	Potency & Assay	CA
23 Dec 2020Drug	CLASS II	Sildenafil Tablets USP 100 mg recalled by AVKARE	Avkare	Hidden Drug Ingredients	Nationwide
23 Dec 2020Drug	CLASS I	TraZODONE Hydrochloride Tablets USP 100 mg recalled by AVKARE	Avkare	Hidden Drug Ingredients	Nationwide
18 Nov 2020Drug	CLASS II	Mesalamine Delayed-Release Tablets, USP (Once-Daily) recalled by AVKARE	Avkare	Potency & Assay	Nationwide
24 Jun 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) recalled	Avkare	Nitrosamine Impurity	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.