Avkare recalls
Avkare appears in 62 official U.S. recall notices indexed by RecallRadar, most recently on 2026-03-04.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 62 |
|---|---|
| Published | 2015-03-11 to 2026-03-04 |
| By agency | FDA Drug (62) |
| By classification | Class II (47), Class III (13), Class I (2) |
| By status | terminated (39), ongoing (22), completed (1) |
| Distribution named in notices | AZ, CA, CO, MO, US, WA |
Recalls
- Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com…
FDA Drug · Class II · 2026-03-04 · Avkare
Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. - Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class II · 2026-01-14 · Avkare
Reason: Out of specification for dissolution. - 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, 3x28 tablets blister c…
FDA Drug · Class II · 2025-10-15 · Avkare
Reason: Failed Content Uniformity Specifications - chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 3847…
FDA Drug · Class II · 2025-09-17 · Avkare
Reason: Presence of a foreign substance. - chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 384…
FDA Drug · Class II · 2025-09-17 · Avkare
Reason: Presence of a foreign substance. - Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class III · 2025-07-09 · Avkare
Reason: Failed Impurity/Degradation Specifications - Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class III · 2025-07-09 · Avkare
Reason: Failed Impurity/Degradation Specifications - Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC…
FDA Drug · Class II · 2025-06-18 · Avkare
Reason: Failed Dissolution Specifications - Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class II · 2025-06-18 · Avkare
Reason: Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules - Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of…
FDA Drug · Class II · 2025-02-26 · Avkare
Reason: 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%) - Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class II · 2025-02-19 · Avkare
Reason: Out of Specification for Dissolution - Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE,…
FDA Drug · Class III · 2025-01-08 · Avkare
Reason: LABELING: LABEL MIX-UP - Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
FDA Drug · Class II · 2025-01-08 · Avkare
Reason: Failed Dissolution Specifications - Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN…
FDA Drug · Class III · 2025-01-08 · Avkare
Reason: LABELING: LABEL MIX-UP - Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
FDA Drug · Class II · 2024-12-11 · Avkare
Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. - Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
FDA Drug · Class II · 2024-12-11 · Avkare
Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. - Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class II · 2024-12-11 · Avkare
Reason: Labeling: Label Mix-Up - Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
FDA Drug · Class II · 2024-12-11 · Avkare
Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. - Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class II · 2024-12-11 · Avkare
Reason: Labeling: Label Mix-Up - Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC…
FDA Drug · Class I · 2024-04-24 · Avkare
Reason: Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. - Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE…
FDA Drug · Class II · 2023-09-13 · Avkare
Reason: Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste - Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ.…
FDA Drug · Class II · 2023-09-13 · Avkare
Reason: 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 - Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
FDA Drug · Class III · 2023-06-21 · Avkare
Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. - Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
FDA Drug · Class II · 2023-01-04 · Avkare
Reason: Failed impurities/degradation specifications: Out of specification for unknown impurities. - Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc
FDA Drug · Class III · 2022-08-17 · Avkare
Reason: Labeling: Label Error on Declared Strength - Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478
FDA Drug · Class III · 2021-06-23 · Avkare
Reason: Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. - TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
FDA Drug · Class I · 2020-12-23 · Avkare
Reason: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. - Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01
FDA Drug · Class II · 2020-12-23 · Avkare
Reason: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. - Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2020-11-18 · Avkare
Reason: Failed Dissolution Specifications - Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (N…
FDA Drug · Class II · 2020-06-24 · Avkare
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15)
FDA Drug · Class II · 2020-06-24 · Avkare
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: A…
FDA Drug · Class III · 2020-06-10 · Avkare
Reason: Presence of Foreign Substance consistent with granules from desiccant packs used during storage - Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 502…
FDA Drug · Class II · 2020-01-22 · Avkare
Reason: Failed Impurities/Degradation Specifications: High out of specification results for related compounds. - AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2019-12-04 · Avkare
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API - AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2019-12-04 · Avkare
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API - AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2019-11-06 · Avkare
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API - AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2019-11-06 · Avkare
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API - AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50
FDA Drug · Class II · 2019-09-18 · Avkare
Reason: Failed Stability Specifications. - Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc
FDA Drug · Class II · 2019-05-08 · Avkare
Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million. - Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc
FDA Drug · Class II · 2019-05-08 · Avkare
Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million. - Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc
FDA Drug · Class III · 2019-04-17 · Avkare
Reason: Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) - Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE I…
FDA Drug · Class II · 2019-03-27 · Avkare
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified - Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc
FDA Drug · Class II · 2019-03-27 · Avkare
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified - Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE…
FDA Drug · Class II · 2019-03-27 · Avkare
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified - Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx…
FDA Drug · Class III · 2019-03-20 · Avkare
Reason: Failed Dissolution Specifications - Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc
FDA Drug · Class II · 2018-12-05 · Avkare
Reason: Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product - AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2018-09-12 · Avkare
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2018-09-12 · Avkare
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2018-09-12 · Avkare
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2018-09-12 · Avkare
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.