The Recall Desk

Manufacturer

Aidarex Pharmaceuticals LLC

10 recalls in our database name Aidarex Pharmaceuticals LLC as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
1
Most recent
2018-08-01

Of the 10 recalls from Aidarex Pharmaceuticals LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (10%) 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.

1–10 of 10

  • ModerateFDA (Drugs)·D-0991-2018·2018-08-01

    Aidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product

    Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg due to out-of-specification results for a degradation product during commercial stability.

    Product
    Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0992-2018·2018-08-01

    Aidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product

    Aidarex Pharmaceuticals is recalling 25 bottles of Enalapril Maleate 5mg due to out-of-specification degradation results during stability testing.

    Product
    Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0990-2018·2018-08-01

    Aidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues

    Aidarex Pharmaceuticals is recalling 11 bottles of Enalapril Maleate 2.5mg because out-of-specification degradation products were found during stability testing.

    Product
    Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0810-2018·2018-05-23

    Aidarex Recalls Ferrous Sulfate Tablets Due to Foreign Material Presence

    Aidarex Pharmaceuticals LLC is recalling 450 bottles of Ferrous Sulfate 325 MG tablets distributed in Florida because foreign tablets or capsules were found in the product.

    Product
    Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0053-2018·2017-11-01

    Aidarex Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg tablets distributed in Florida due to out-of-specification impurities.

    Product
    ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1162-2017·2017-09-20

    Aidarex Recalls Phentermine Capsules Due to Impurity Test Failures

    Aidarex Pharmaceuticals is recalling 35 bottles of Phentermine 15 mg capsules because they failed impurity specifications during stability testing.

    Product
    Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-1061-2016·2016-07-06

    Aidarex Recalls Ciprofloxacin Ophthalmic Solution Due to Unknown Impurity

    Aidarex Pharmaceuticals is recalling 599 bottles of Ciprofloxacin Ophthalmic Solution because testing revealed out-of-specification results for an unknown impurity.

    Product
    Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0975-2016·2016-06-15

    Aidarex Recalls Chlorhexidine Gluconate Oral Rinse Due to Impurity

    Aidarex Pharmaceuticals is recalling 292 bottles of Chlorhexidine Gluconate 0.12% Oral Rinse because the product failed impurity specifications.

    Product
    CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
    Category
    Drug
    Distribution
    4 states
  • LowFDA (Drugs)·D-0974-2016·2016-06-15

    Aidarex Recalls Ceftriaxone for Injection Due to Manufacturing Deviations

    Aidarex Pharmaceuticals is recalling Ceftriaxone for Injection due to out-of-specification intermediates during manufacturing.

    Product
    CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0042-2015·2014-10-29

    Ciprofloxacin 500 mg Tablets Recalled Due to Foreign Tramadol Tablets

    Aidarex Pharmaceuticals is recalling Ciprofloxacin 500 mg tablets because Tramadol 50 mg tablets were found in the bottles.

    Product
    Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
    Category
    Drug
    Distribution
    Distributed nationwide