Pulaski, TN, United States
AVKARE Inc. recalls
36 recalls recorded since 2018, most recently on 13 February 2026. 15 are listed as ongoing. Status and classification are as published by the FDA.
Recalls36
Ongoing (FDA)15
Terminated or completed21
Class I (FDA)2
Ongoing Class II Drugs
- Recall started
- 13 February 2026
- Reason
- Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0341-2026
- Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Ongoing Class II Drugs
- Recall started
- 31 December 2025
- Reason
- Out of specification for dissolution.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0292-2026
- Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
Ongoing Class II Drugs
- Recall started
- 2 September 2025
- Reason
- Failed Content Uniformity Specifications
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0007-2026
- 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 cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton ND
Ongoing Class II Drugs
- Recall started
- 25 August 2025
- Reason
- Presence of a foreign substance.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0643-2025, D-0644-2025
- chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
- chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Ongoing Class III Drugs
- Recall started
- 26 June 2025
- Reason
- Failed Impurity/Degradation Specifications
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0528-2025, D-0529-2025
- Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
- Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Ongoing Class II Drugs
- Recall started
- 13 May 2025
- Reason
- Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0460-2025
- Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Ongoing Class II Drugs
- Recall started
- 9 May 2025
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0461-2025
- Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Ongoing Class II Drugs
- Recall started
- 4 February 2025
- 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%)
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0229-2025
- Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
Ongoing Class II Drugs
- Recall started
- 21 January 2025
- Reason
- Out of Specification for Dissolution
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0224-2025
- Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Ongoing Class III Drugs
- Recall started
- 18 December 2024
- Reason
- LABELING: LABEL MIX-UP
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0175-2025, D-0176-2025
- Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
- Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
Ongoing Class II Drugs
- Recall started
- 4 December 2024
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0168-2025
- Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
Ongoing Class II Drugs
- Recall started
- 27 November 2024
- Reason
- CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0109-2025, D-0110-2025, D-0108-2025
- Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
- Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Ongoing Class II Drugs
- Recall started
- 18 October 2024
- Reason
- Labeling: Label Mix-Up
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0103-2025, D-0104-2025
- Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
- Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Terminated Class I Drugs
- Recall started
- 28 March 2024
- Terminated
- 23 August 2024
- Reason
- Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0444-2024
- 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 50268-086-12.
Terminated Class II Drugs
- Recall started
- 11 August 2023
- Terminated
- 29 April 2024
- Reason
- Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
- Distribution
- Affected product was distributed to nineteen (19) consignees within the united states.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1147-2023, D-1146-2023
- Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478
- Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478
Ongoing Class III Drugs
- Recall started
- 13 June 2023
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0875-2023
- Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Completed Class II Drugs
- Recall started
- 22 December 2022
- Reason
- Failed impurities/degradation specifications: Out of specification for unknown impurities.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0091-2023
- Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Terminated Class III Drugs
- Recall started
- 20 July 2022
- Terminated
- 30 September 2024
- Reason
- Labeling: Label Error on Declared Strength
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1329-2022
- Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
Terminated Class III Drugs
- Recall started
- 9 June 2021
- Terminated
- 2 June 2023
- Reason
- Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
- Distribution
- Distributed in Los Angeles California
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0631-2021
- Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Terminated Class I, Class II Drugs
- Recall started
- 7 December 2020
- Terminated
- 16 October 2023
- Reason
- Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
- Distribution
- Nationwide within the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0168-2021, D-0167-2021
- TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
- Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Terminated Class II Drugs
- Recall started
- 30 October 2020
- Terminated
- 2 June 2023
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0070-2021
- Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
Terminated Class II Drugs
- Recall started
- 4 June 2020
- Terminated
- 14 January 2022
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1305-2020, D-1304-2020
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-61
- 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 (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 3847
Terminated Class III Drugs
- Recall started
- 28 May 2020
- Terminated
- 22 October 2021
- Reason
- Presence of Foreign Substance consistent with granules from desiccant packs used during storage
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1289-2020
- 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: AvKARE, Inc. Pulaski, TN 38478.
Terminated Class II Drugs
- Recall started
- 7 January 2020
- Terminated
- 14 July 2021
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0661-2020
- Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.
Terminated Class II Drugs
- Recall started
- 14 November 2019
- Terminated
- 27 October 2021
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0524-2020, D-0525-2020
- AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-
- AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
Terminated Class II Drugs
- Recall started
- 17 October 2019
- Terminated
- 21 October 2020
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Distribution
- CO, MO
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0164-2020, D-0165-2020
- AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Terminated Class II Drugs
- Recall started
- 28 August 2019
- Terminated
- 27 October 2021
- Reason
- Failed Stability Specifications.
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1875-2019
- AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Ongoing Class II Drugs
- Recall started
- 24 April 2019
- 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.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1249-2019, D-1250-2019
- Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
- Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Terminated Class III Drugs
- Recall started
- 3 April 2019
- Terminated
- 7 May 2020
- Reason
- Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
- Distribution
- AZ, CO
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1122-2019
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Terminated Class II Drugs
- Recall started
- 5 March 2019
- Terminated
- 7 December 2020
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1046-2019, D-1044-2019, D-1045-2019
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
- Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
Terminated Class III Drugs
- Recall started
- 1 March 2019
- Terminated
- 14 January 2020
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0990-2019
- 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 Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Terminated Class II Drugs
- Recall started
- 20 November 2018
- Terminated
- 7 May 2020
- Reason
- Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
- Distribution
- WA only
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0285-2019
- Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408
Terminated Class II Drugs
- Recall started
- 14 August 2018
- Terminated
- 7 May 2020
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1130-2018, D-1132-2018, D-1133-2018, D-1131-2018
- Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Terminated Class II Drugs
- Recall started
- 18 July 2018
- Terminated
- 7 May 2020
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1176-2018, D-1175-2018, D-1174-2018, D-1173-2018, D-1177-2018
- AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
- AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
- AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90
- AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
- AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
Terminated Class II Drugs
- Recall started
- 30 March 2018
- Terminated
- 4 June 2020
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0633-2018
- Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
Terminated Class II Drugs
- Recall started
- 3 January 2018
- Terminated
- 8 May 2020
- Reason
- Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0222-2018
- Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.