Recalls by year
15
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
March 4, 2026DrugsFDA
AvKARE recalls Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38
Hazard: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
January 14, 2026DrugsFDA
AvKARE recalls Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski,
Hazard: Out of specification for dissolution.
October 15, 2025DrugsFDA
AvKARE recalls Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x2
Hazard: Failed Content Uniformity Specifications
September 17, 2025DrugsFDA
AvKARE recalls chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKar
Hazard: Presence of a foreign substance.
September 17, 2025DrugsFDA
AvKARE recalls chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare
Hazard: Presence of a foreign substance.
July 9, 2025DrugsFDA
AvKARE recalls Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906
Hazard: Failed Impurity/Degradation Specifications
July 9, 2025DrugsFDA
AvKARE recalls Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905
Hazard: Failed Impurity/Degradation Specifications
June 18, 2025DrugsFDA
AvKARE recalls Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pul
Hazard: Failed Dissolution Specifications
June 18, 2025DrugsFDA
AvKARE recalls Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 3847
Hazard: Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
February 26, 2025DrugsFDA
AvKARE recalls Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal
Hazard: Subpotent 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%)
February 19, 2025DrugsFDA
AvKARE recalls Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. N
Hazard: Out of Specification for Dissolution
January 8, 2025DrugsFDA
AvKARE recalls Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by
Hazard: LABELING: LABEL MIX-UP
January 8, 2025DrugsFDA
AvKARE recalls Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Dist
Hazard: LABELING: LABEL MIX-UP
January 8, 2025DrugsFDA
AvKARE recalls Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc.
Hazard: Failed Dissolution Specifications
December 11, 2024DrugsFDA
AvKARE recalls Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Hazard: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
December 11, 2024DrugsFDA
AvKARE recalls Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Hazard: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
December 11, 2024DrugsFDA
AvKARE recalls Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Hazard: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
December 11, 2024DrugsFDA
AvKARE recalls Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902
Hazard: Labeling: Label Mix-Up
December 11, 2024DrugsFDA
AvKARE recalls Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-90
Hazard: Labeling: Label Mix-Up
April 24, 2024DrugsFDA
AvKARE recalls Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pul
Hazard: Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
September 13, 2023DrugsFDA
AVKARE LLC recalls Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manuf
Hazard: Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
September 13, 2023DrugsFDA
AVKARE LLC recalls Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearm
Hazard: Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
June 21, 2023DrugsFDA
AVKARE LLC recalls Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, N
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
January 4, 2023DrugsFDA
AVKARE LLC recalls Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 384
Hazard: Failed impurities/degradation specifications: Out of specification for unknown impurities.
August 17, 2022DrugsFDA
AVKARE Inc. recalls Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 4229
Hazard: Labeling: Label Error on Declared Strength
June 23, 2021DrugsFDA
AVKARE Inc. recalls Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-6
Hazard: Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
December 23, 2020DrugsFDA
AVKARE Inc. recalls TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC
Hazard: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
December 23, 2020DrugsFDA
AVKARE Inc. recalls Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Hazard: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
November 18, 2020DrugsFDA
AVKARE Inc. recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc
Hazard: Failed Dissolution Specifications
June 24, 2020DrugsFDA
AVKARE Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level