The Recall Desk

Manufacturer

Zydus Pharmaceuticals (USA) Inc

95 recalls in our database name Zydus Pharmaceuticals (USA) Inc as the manufacturing or recalling firm.

What the numbers show

Total
95
Critical
0
Severe
20
Most recent
2026-08-12

Of the 95 recalls from Zydus Pharmaceuticals (USA) Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (21%) 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.

76–95 of 95

  • ModerateFDA (Drugs)·D-1042-2017·2017-08-09

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1043-2017·2017-08-09

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2017·2017-04-05

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed dissolution specifications and long-term stability testing.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1491-2016·2016-09-14

    Zydus Recalls Bromocriptine Mesylate Capsules Due to Stability Test Failures

    Zydus Pharmaceuticals is recalling 14,808 bottles of Bromocriptine Mesylate 5 mg capsules because stability samples failed impurity tests.

    Product
    BROMOCRIPTINE MESYLATE — BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1461-2016·2016-08-24

    Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures

    Zydus Pharmaceuticals USA Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules because retained samples failed dissolution specifications.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1460-2016·2016-08-24

    Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures

    Zydus Pharmaceuticals is recalling 223,776 bottles of Venlafaxine Hydrochloride ER capsules because retained samples failed dissolution specifications.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0725-2016·2016-03-02

    Zydus Recalls Risperidone Tablets Due to Impurity Failure

    Zydus Pharmaceuticals is recalling 9,504 bottles of 2 mg risperidone tablets because they failed impurity specifications. The affected lot is MP4967.

    Product
    risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0325-2015·2014-12-31

    Zydus Recalls Benzonatate Capsules Due to Wet or Leaking Defects

    Zydus Pharmaceuticals USA is recalling 19,536 units of Benzonatate capsules because some are wet or leaking. The recall is nationwide.

    Product
    BENZONATATE — BENZONATATE (BENZONATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0299-2015·2014-12-24

    Zydus Recalls Benzonatate Capsules Due to Wet or Leaking Capsules

    Zydus Pharmaceuticals is recalling 58,920 bottles of Benzonatate Capsules, 200 mg, because some capsules are wet or leaking.

    Product
    Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0289-2015·2014-12-10

    Zydus Recalls Benzonatate Capsules Due to Foreign Capsule Contamination

    Zydus Pharmaceuticals USA is recalling Benzonatate 200 mg capsules because they may contain foreign 100 mg capsules.

    Product
    BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0257-2015·2014-12-03

    Zydus Recalls Amlodipine Besylate Tablets Due to Discoloration

    Zydus Pharmaceuticals is recalling Amlodipine Besylate 10 mg tablets due to brown spots embedded in the product.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0007-2015·2014-10-15

    Zydus Recalls Atenolol Tablets Due to Superpotent Drug Complaint

    Zydus Pharmaceuticals is recalling 5,400 bottles of Atenolol 25 mg tablets nationwide after a pharmacist reported that several tablets appeared noticeably thicker.

    Product
    ATENOLOL — ATENOLOL (ATENOLOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1342-2014·2014-05-28

    Zydus Recalls Promethazine Hydrochloride Tablets Due to Foreign Tablet Presence

    Zydus Pharmaceuticals USA Inc. is recalling 10,200 bottles of Promethazine Hydrochloride 25 mg tablets because atenolol 25 mg tablets were found mixed into the bottles.

    Product
    PROMETHAZINE HYDROCHLORIDE — PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-838-2013·2013-08-14

    Zydus Recalls Warfarin Sodium Tablets Due to Oversized Pills

    Zydus Pharmaceuticals is recalling 960 bottles of Warfarin Sodium Tablets 2 mg because a pharmacist found three oversized tablets in one bottle.

    Product
    Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-202-2013·2013-04-03

    Zydus Recalls Venlafaxine Hydrochloride Tablets Due to Broken Tablets

    Zydus Pharmaceuticals USA Inc. is recalling 13,320 bottles of Venlafaxine Hydrochloride 75 mg tablets due to a complaint of excessive broken or chipped tablets.

    Product
    VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1428-2012·2012-08-08

    Zydus Recalls Metformin Tablets Due to Foreign Substance Presence

    Zydus Pharmaceuticals is recalling 1,176 bottles of Metformin Hydrochloride 1000 mg tablets because a pharmacist reported brown specks and metal shavings on the tablets.

    Product
    Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Zydus Pharmaceuticals (United States)

company in Pennington, United States

Country
United States
Founded
2002

Official website

Source: Wikidata (Q55454487), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.