The Recall Desk

Manufacturer

AVKARE Inc.

33 recalls in our database name AVKARE Inc. as the manufacturing or recalling firm.

What the numbers show

Total
33
Critical
1
Severe
15
Most recent
2022-08-17

Of the 33 recalls from AVKARE Inc. we have scored against our rubric, 1 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (45%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 33

  • ModerateFDA (Drugs)·D-1329-2022·2022-08-17

    Lamotrigine Tablets Recalled for Label Strength Error

    AVKARE Inc. is recalling 8,328 bottles of Lamotrigine Tablets, USP 100 mg nationwide due to a labeling error in the declared strength.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0631-2021·2021-06-23

    Phytonadione Tablets 5 mg Recalled Due to Failed Impurities Specification

    AVKARE Inc. is recalling Phytonadione Tablets 5 mg because the impurity degradant D level failed to meet specification. The affected lot was distributed in Los Angeles, California.

    Product
    Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0168-2021·2020-12-23

    AvKare Recalls Trazodone Hydrochloride Tablets Due to Sildenafil Packaging Mix-Up

    AvKare Inc. is recalling 14,368 bottles of Trazodone Hydrochloride Tablets 100 mg because they were inadvertently packaged with sildenafil.

    Product
    TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0167-2021·2020-12-23

    AvKARE Recalls Sildenafil Tablets Due to Packaging Mix-Up with Trazodone

    AvKARE Inc. is recalling 38,715 bottles of Sildenafil 100 mg tablets because they were inadvertently packaged with trazodone at a third-party facility.

    Product
    Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0070-2021·2020-11-18

    AvKARE Recalls Mesalamine Tablets for Failed Dissolution Specifications

    AvKARE Inc. is recalling specific lots of Mesalamine Delayed-Release Tablets because they failed to meet 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1305-2020·2020-06-24

    AvKARE Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    AvKARE Inc. is recalling Metformin Hydrochloride Extended-Release Tablets because 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. Pulas
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1304-2020·2020-06-24

    AvKARE Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    AvKARE Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1289-2020·2020-06-10

    AvKARE Recalls Lamotrigine Tablets Due to Foreign Substance Presence

    AvKARE Inc. is recalling 4,124 bottles of Lamotrigine 150 mg tablets because they contain foreign substance consistent with desiccant pack granules.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0661-2020·2020-01-22

    AvKARE Recalls Dutasteride Capsules Due to Impurity Specification Failures

    AvKARE Inc. is recalling specific lots of Dutasteride Capsules, 0.5 mg, because they failed impurity and degradation specifications.

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0524-2020·2019-12-04

    AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

    AVKARE Inc. is recalling specific lots of Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0525-2020·2019-12-04

    AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

    AVKARE Inc. is recalling specific lots of Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0164-2020·2019-11-06

    AvKare Recalls Ranitidine Capsules Due to NDMA Impurity

    AvKare is recalling Ranitidine Hydrochloride Capsules 150 mg because N-nitrosodimethylamine (NDMA) was found in the active ingredient.

    Product
    AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0165-2020·2019-11-06

    AVKARE Recalls Ranitidine Hydrochloride Capsules Due to NDMA Impurity

    AVKARE Inc. is recalling Ranitidine Hydrochloride Capsules 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA). The affected bottles were distributed in Colorado and Missouri.

    Product
    AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1249-2019·2019-05-08

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because FDA testing found an impurity above acceptable levels.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1250-2019·2019-05-08

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium Tablets 25 mg because FDA testing found an impurity above acceptable levels.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1122-2019·2019-04-17

    AvKARE Recalls Telmisartan and Amlodipine Tablets Due to Impurities

    AvKARE Inc. is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg due to failed impurities and degradation specifications.

    Product
    Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1045-2019·2019-03-27

    AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1046-2019·2019-03-27

    AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1044-2019·2019-03-27

    AvKARE Recalls Losartan Potassium Tablets Due to Impurity

    AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0285-2019·2018-12-05

    Germ Bloc Health Hand Sanitizer Foam Recalled for Pseudomonas Contamination

    AVKARE Inc. is recalling specific lots of Germ Bloc Health Hand Sanitizer Foam due to the presence of Pseudomonas aeruginosa.

    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
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1133-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity

    AvKARE Inc. is recalling Valsartan Tablets 320 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1132-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    AvKARE, Inc. is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.

    Product
    Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1130-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    AvKARE is recalling Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.

    Product
    Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide