The Recall Desk

Manufacturer

Direct Rx

37 recalls in our database name Direct Rx as the manufacturing or recalling firm.

What the numbers show

Total
37
Critical
0
Severe
5
Most recent
2026-07-01

Of the 37 recalls from Direct Rx we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (14%) 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.

26–37 of 37

  • ModerateFDA (Drugs)·D-0888-2022·2022-06-01

    Zonisamide Capsules USP recalled for quality control system deviation

    Direct Rx is recalling Zonisamide Capsules USP 100 mg, lot 23JY2124, nationwide due to gaps in the quality control microbiology laboratory that could affect product verification.

    Product
    Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0714-2022·2022-03-30

    Diclofenac Sodium Topical Solution recalled due to leaking containers

    Direct Rx is recalling Diclofenac Sodium Topical Solution 1.5% (150 mL) nationwide due to defective containers that may leak. Consumers who have purchased this product should stop use and contact their pharmacy or physician.

    Product
    Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0651-2022·2022-03-16

    Alprazolam 2 mg tablets recalled due to potential cross-contamination

    Direct Rx is recalling Alprazolam C-IV 2 mg tablets (Lot #07NO1901, expiration 5/31/22) distributed in Florida, Georgia, and Louisiana due to potential cross-contamination identified at the contract manufacturer Ultra Tab Laboratories Inc.

    Product
    Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0650-2022·2022-03-16

    Alprazolam 1 mg recalled for potential cross-contamination at manufacturer

    Direct Rx is recalling Alprazolam C-IV 1 mg 60-count bottles due to potential cross-contamination at the contract manufacturer, Ultra Tab Laboratories Inc. The recall affects 16 bottles distributed to Florida, Georgia, and Louisiana.

    Product
    Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0637-2022·2022-03-09

    Moxifloxacin Ophthalmic Solution Recalled for Failed Impurity Specifications

    Direct Rx is recalling Moxifloxacin Ophthalmic Solution USP 0.5% due to failed impurities and degradation specifications. The recall affects 44 bottles distributed in Florida.

    Product
    Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0829-2021·2021-09-29

    Zonisamide 100 mg Capsules Recalled Due to Quality Control Gaps

    Direct Rx is recalling Zonisamide 100 mg Capsules (30-count bottles, Lot #17JU2118, expiration 5/31/23) distributed in Florida due to gaps in the quality system in the Quality Control microbiology laboratory.

    Product
    Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0300-2021·2021-03-24

    Direct Rx Recalls Nortriptyline HCL Capsules Due to cGMP Deviation

    Direct Rx is recalling 17 bottles of Nortriptyline HCL 10 mg capsules because the active ingredient was taken from an unqualified supplier lot.

    Product
    Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0058-2021·2020-11-11

    Direct Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    Direct Rx is recalling 88 bottles of Metformin Hydrochloride Extended Release 500 mg in Florida due to NDMA impurity levels above acceptable intake.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0016-2021·2020-10-14

    Direct Rx Recalls Ranitidine 150 mg Tablets Due to NDMA Impurity

    Direct Rx is recalling specific lots of Ranitidine 150 mg tablets because an NDMA impurity was detected. The affected products were distributed in Florida and Georgia.

    Product
    Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0018-2021·2020-10-14

    Direct Rx Recalls Losartan Potassium 100 mg Tablets Due to Impurity

    Direct Rx is recalling 33 bottles of Losartan Potassium 100 mg tablets found to contain an impurity above acceptable levels.

    Product
    Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0017-2021·2020-10-14

    Direct Rx Recalls Ranitidine 300 mg Tablets Due to NDMA Impurity

    Direct Rx is recalling 26 bottles of Ranitidine 300 mg tablets because the product was found to contain the NDMA impurity.

    Product
    Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0032-2021·2020-10-07

    Losartan Pot/HCTZ 50/12.5 mg Recalled Due to Impurity Detection

    Direct Rx is recalling 33 bottles of Losartan Pot/HCTZ 50/12.5 mg tablets distributed in Florida due to trace amounts of impurity NMBA.

    Product
    Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
    Category
    Drug
    Distribution
    1 state