thejoe AVKARE Inc.

AVKARE Inc.: 33 FDA recall reports

Every drug recall the FDA has published for AVKARE Inc.. The fault, and how the agency graded it.

33Reports

1Class I

2Ongoing

2022-08-17Most recent

1 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	24
Class III	8
Class I	1

By year reported

Year	Reports
2015	2
2017	3
2018	7
2019	12
2020	7
2021	1
2022	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478

D-1329-2022 · Class III · reported 2022-08-17 · Terminated

Why it was recalled: Labeling: Label Error on Declared Strength
Product: 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
Where it went: Nationwide within the United States
How much: 8328 bottles

Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. N

D-0631-2021 · Class III · reported 2021-06-23 · Terminated

Why it was recalled: Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Product: Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Where it went: Distributed in Los Angeles California
How much: 10 cartons

Class I

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 3

D-0168-2021 · Class I · reported 2020-12-23 · Terminated

Why it was recalled: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Product: TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
Where it went: Nationwide within the U.S.
How much: 14368 bottles

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 4229

D-0167-2021 · Class II · reported 2020-12-23 · Terminated

Why it was recalled: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Product: Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Where it went: Nationwide within the U.S.
How much: 38715 bottles

Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: A

D-0070-2021 · Class II · reported 2020-11-18 · Terminated

Why it was recalled: Failed Dissolution Specifications
Product: 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
Where it went: Nationwide
How much: 15,678 bottles

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC

D-1305-2020 · Class II · reported 2020-06-24 · Terminated

Why it was recalled: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product: 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 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Where it went: Nationwide.
How much: 1,586,913 bottles

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC

D-1304-2020 · Class II · reported 2020-06-24 · Terminated

Why it was recalled: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product: 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 38478
Where it went: Nationwide.
How much: 88,545 bottles

Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 4229

D-1289-2020 · Class III · reported 2020-06-10 · Terminated

Why it was recalled: Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Product: 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.
Where it went: Nationwide in the U.S.
How much: 4124 bottles

Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc

D-0661-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Product: 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.
Where it went: Nationwide in the USA.
How much: 3,989 cartons

AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by

D-0524-2020 · Class II · reported 2019-12-04 · Terminated

Why it was recalled: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product: 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 42291-724-18; c) 60 tablets NDC 42291-724-60
Where it went: Nationwide.
How much: 631,138 bottles

AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tabl

D-0525-2020 · Class II · reported 2019-12-04 · Terminated

Why it was recalled: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product: 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
Where it went: Nationwide.
How much: 104,797 bottles

AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufac

D-0164-2020 · Class II · reported 2019-11-06 · Terminated

Why it was recalled: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product: AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Where it went: CO, MO
How much: 7293 bottles

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufac

D-0165-2020 · Class II · reported 2019-11-06 · Terminated

Why it was recalled: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product: AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Where it went: CO, MO
How much: 1351 bottles

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

D-1875-2019 · Class II · reported 2019-09-18 · Terminated

Why it was recalled: Failed Stability Specifications.
Product: AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Where it went: Nationwide in the U.S.
How much: 5953 bottles

Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: Av

D-1249-2019 · Class II · reported 2019-05-08 · Ongoing

Why it was recalled: 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.
Product: Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Where it went: Nationwide
How much: 1438 cartons (71,900 tablets)

Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: Av

D-1250-2019 · Class II · reported 2019-05-08 · Ongoing

Why it was recalled: 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.
Product: Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Where it went: Nationwide
How much: 846 cartons (42,300 tablets)

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, T

D-1122-2019 · Class III · reported 2019-04-17 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Product: Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Where it went: AZ, CO
How much: 397 bottles

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx O

D-1046-2019 · Class II · reported 2019-03-27 · Terminated

Why it was recalled: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Product: 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
Where it went: Nationwide.
How much: N/A

Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc.

D-1044-2019 · Class II · reported 2019-03-27 · Terminated

Why it was recalled: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Product: 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
Where it went: Nationwide.
How much: N/A

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx On

D-1045-2019 · Class II · reported 2019-03-27 · Terminated

Why it was recalled: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Product: 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
Where it went: Nationwide.
How much: N/A

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (

D-0990-2019 · Class III · reported 2019-03-20 · Terminated

Why it was recalled: Failed Dissolution Specifications
Product: 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
Where it went: Nationwide.
How much: a) 2947 and b) 3379

Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. P

D-0285-2019 · Class II · reported 2018-12-05 · Terminated

Why it was recalled: Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Product: 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
Where it went: WA only
How much: 1602 bags

Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, In

D-1130-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product: Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Where it went: U.S. Nationwide
How much: 6776 cartons (338,800 tablets)

Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, I

D-1132-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product: Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Where it went: U.S. Nationwide
How much: 818 cartons (40,900 tablets)

Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, In

D-1133-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product: Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Where it went: U.S. Nationwide
How much: 1496 cartons (44,880 tablets)

Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, In

D-1131-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product: Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Where it went: U.S. Nationwide
How much: 728 cartons (36,400 tablets)

Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pu

D-0633-2018 · Class II · reported 2018-04-25 · Terminated

Why it was recalled: Failed Dissolution Specifications
Product: Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
Where it went: Nationwide
How much: 2135 cartons

Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pula

D-0222-2018 · Class II · reported 2018-01-24 · Terminated

Why it was recalled: Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Product: Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
Where it went: Nationwide in the USA
How much: 237 cartons

Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister U

D-0055-2018 · Class II · reported 2017-11-08 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Product: Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Where it went: Nationwide in the USA
How much: 274 cartons

Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pula

D-1094-2017 · Class III · reported 2017-08-23 · Terminated

Why it was recalled: Failed impurities/degradation specifications: Out of specification for a related compound C.
Product: Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
Where it went: Nationwide
How much: 1172 cartons (23440 tablets)

Showing the 30 most recent of 33. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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