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.

26–33 of 33

  • SevereFDA (Drugs)·D-1131-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity

    AvKARE is recalling specific lots of Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0633-2018·2018-04-25

    AvKARE Recalls Amantadine HCl Capsules for Dissolution Failure

    AvKARE Inc. is recalling 2,135 cartons of Amantadine HCl Capsules, 100 mg, because the product failed dissolution specifications.

    Product
    AMANTADINE HCL — AMANTADINE HCL (AMANTADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0222-2018·2018-01-24

    AvKARE Recalls Lovastatin Tablets Due to Dissolution Failures

    AvKARE Inc. is recalling 237 cartons of Lovastatin Tablets USP, 40 mg, because annual stability testing revealed low dissolution results.

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0055-2018·2017-11-08

    AvKARE Recalls Duloxetine Capsules Due to Slightly Elevated Phthalic Acid

    AvKARE is recalling 274 cartons of Duloxetine Delayed-release Capsules 20 mg due to 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1094-2017·2017-08-23

    AvKARE Recalls Voriconazole Tablets Due to Impurity Specification Failure

    AvKARE Inc. is recalling specific lots of Voriconazole Tablets, 200 mg, because they failed impurity specifications for a related compound.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0610-2017·2017-03-29

    AvKARE Recalls Famciclovir Tablets Due to Impurity Levels

    AvKARE Inc. is recalling 116 cartons of 500 mg Famciclovir tablets because the product exceeded specifications for unknown impurities.

    Product
    Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0401-2015·2015-03-11

    AvKARE Recalls Subpotent Quinapril Tablets Due to Low Dosage

    AvKARE Inc. is voluntarily recalling 214 unit dose packs of Quinapril 5 mg tablets nationwide because the medication is subpotent.

    Product
    Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0402-2015·2015-03-11

    AvKARE Recalls Subpotent Quinapril Tablets Due to Low Drug Content

    AvKARE Inc. is voluntarily recalling 431 unit dose packs of Quinapril Tablets USP, 40 mg, because the medication was found to be subpotent.

    Product
    Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15
    Category
    Drug
    Distribution
    Distributed nationwide