The Recall Desk

Manufacturer

AvKARE

20 recalls in our database name AvKARE as the manufacturing or recalling firm.

What the numbers show

Total
20
Critical
0
Severe
1
Most recent
2026-03-04

Of the 20 recalls from AvKARE we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) 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.

1–20 of 20

  • HighFDA (Drugs)·D-0007-2026·2025-10-15

    Oral contraceptive tablets recalled after failing content uniformity specifications

    AvKARE is recalling 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets USP from one lot after the product failed content uniformity specifications.

    Product
    NORGESTIMATE AND ETHINYL ESTRADIOL — NORGESTIMATE AND ETHINYL ESTRADIOL (NORGESTIMATE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0643-2025·2025-09-17

    AvKare chlorpromazine unit dose cartons recalled over presence of foreign substance

    Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in 50-tablet unit dose cartons for AvKare, are recalled nationwide for the presence of a foreign substance. 1,512 cartons are affected.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0644-2025·2025-09-17

    AvKare chlorpromazine 100 mg cartons recalled over presence of foreign substance

    Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in 50-tablet unit dose cartons for AvKare, are recalled nationwide for the presence of a foreign substance. 2,003 cartons are affected.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0529-2025·2025-07-09

    Pitavastatin Tablets Recalled for Failed Impurity and Degradation Specifications

    AvKARE is recalling Pitavastatin 2 mg tablets nationwide due to failed impurity and degradation specifications. The affected lots do not meet quality standards for chemical purity.

    Product
    PITAVASTATIN — PITAVASTATIN (PITAVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0460-2025·2025-06-18

    Celecoxib Capsules Recalled for Foreign Tablet Contamination

    AvKARE is recalling Celecoxib 200 mg capsules because one tadalafil 5 mg tablet was found in a 500-count bottle. The contamination poses a risk of unintended drug exposure to patients.

    Product
    CELECOXIB — CELECOXIB (CELECOXIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0461-2025·2025-06-18

    Chlorthalidone Tablets Recalled Due to Failed Dissolution Specifications

    AvKARE is recalling Chlorthalidone Tablets USP 25 mg due to failed dissolution specifications. The defect may affect the drug's therapeutic effectiveness.

    Product
    CHLORTHALIDONE — CHLORTHALIDONE (CHLORTHALIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0224-2025·2025-02-19

    Irbesartan Tablets Recalled Due to Out-of-Specification Dissolution

    AvKARE is recalling Irbesartan Tablets USP 300 mg due to dissolution failure, affecting 341 cartons distributed nationwide. Patients should contact their pharmacist or doctor regarding their medication.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0176-2025·2025-01-08

    Eye drops recalled nationwide due to labeling mix-up

    AvKARE is recalling Polyvinyl Alcohol Ophthalmic Solution eye drops due to a labeling mix-up. The recall affects Lot #0160 and was distributed nationwide.

    Product
    POLYVINYL ALCOHOL — POLYVINYL ALCOHOL (POLYVINYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0175-2025·2025-01-08

    Carboxymethylcellulose sodium eye drops recalled for label mix-up

    AvKARE is recalling Carboxymethylcellulose Sodium Ophthalmic Solution eye drops due to a label mix-up. The recall affects 16,677 cartons distributed nationwide.

    Product
    CARBOXYMETHYLCELLULOSE SODIUM — CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2025·2025-01-08

    AvKARE Nitrofurantoin 100 mg Capsules Recalled for Dissolution Failures

    AvKARE is recalling Nitrofurantoin 100 mg capsules (NDC 50268-625-15, lot 47101, exp. 02/2026) nationwide because they failed dissolution specifications. Affected users should consult their healthcare provider.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2025·2024-12-11

    Sunitinib Malate Capsules Recalled Due to Label Mix-Up

    AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2025·2024-12-11

    Prescription Drug Sunitinib Malate Subject to Label Mix-Up Recall

    AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2025·2024-12-11

    Cinacalcet Tablets Recalled for Elevated Nitrosamine Impurity

    AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.

    Product
    Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2025·2024-12-11

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity Exceeding Limits

    AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.

    Product
    Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2025·2024-12-11

    Cinacalcet Tablets Recalled for Excess Nitrosamine Impurity

    AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.

    Product
    Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0444-2024·2024-04-24

    Atovaquone Oral Suspension Recalled Due to Potential Bacillus Contamination

    AvKARE recalls Atovaquone Oral Suspension due to potential Bacillus cereus contamination of a non-sterile product. The recalled lot (AW0221A, Exp. 08/30/2025) was distributed nationwide; 153 cartons affected.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide