AvKARE recalls
FDA enforcement reports naming AvKARE as the recalling firm.
- Recall reports
- 62
- Class I (serious)
- 2
- Most recent report
- Mar 4, 2026
- Mar 4, 2026Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufac…Drug · AvKAREFailed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.Class II
- Jan 14, 2026Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Ma…Drug · AvKAREOut of specification for dissolution.Class II
- Oct 15, 2025Norgestimate and Ethinyl Estradiol Tablets, USP, 0Drug · AvKAREFailed Content Uniformity SpecificationsClass II
- Sep 17, 2025chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton,…Drug · AvKAREPresence of a foreign substance.Class II
- Sep 17, 2025chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton,…Drug · AvKAREPresence of a foreign substance.Class II
- Jul 9, 2025Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, P…Drug · AvKAREFailed Impurity/Degradation SpecificationsClass III
- Jul 9, 2025Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, P…Drug · AvKAREFailed Impurity/Degradation SpecificationsClass III
- Jun 18, 2025Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx on…Drug · AvKAREFailed Dissolution SpecificationsClass II
- Jun 18, 2025Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactu…Drug · AvKAREPresence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsulesClass II
- Feb 26, 2025Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, T…Drug · AvKARESubpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)Class II
- Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured…
- Carboxymethylcellulose Sodium Ophthalmic Solution 0
- Polyvinyl Alcohol Ophthalmic Solution 1
- Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Onl…
- Sunitinib Malate Capsules, 12
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,…
- Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,…
- Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,…
- Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE,…
- Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx On…
- Sodium Fluoride 1
- Capsaicin Cream 0
- Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured…
- Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufac…
- Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE,…
- Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKA…
- Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pula…
- TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured fo…
- Mesalamine Delayed-Release Tablets, USP 1
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-53…
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611…
- Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle
- Dutasteride Capsules, 0
- AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc
- AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc
- AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 U…
- AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 U…
- AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle
- Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-…
- Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-…
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for:…
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12
- Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufa…
- Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-0…
- Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0
- AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only,…
- AvKARE Valsartan and Hydrochlorothiazide 80 mg/12
- AvKARE Valsartan and Hydrochlorothiazide 160 mg/12
- AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only…
- AvKARE Valsartan and Hydrochlorothiazide 320 mg/12
- Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manuf…
- Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manuf…
- Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manu…
- Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manuf…
- Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactu…
- Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufacture…
- Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per cart…
- Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured…
- Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactu…
- Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured…
- Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured…
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