The Recall Desk

Manufacturer

Zydus Pharmaceuticals (USA) Inc

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

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.

26–47 of 47

  • SevereFDA (Drugs)·D-0442-2025·2025-05-28

    Esomeprazole Magnesium Oral Suspension Recalled for Failed Impurity Specifications

    Zydus Pharmaceuticals is recalling Esomeprazole Magnesium 40 mg delayed-release oral suspension because out-of-specification test results were found for unknown degradation products during stability testing.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2025·2025-05-28

    Esomeprazole Magnesium oral suspension recalled for failed impurity specifications

    Zydus Pharmaceuticals is recalling Esomeprazole Magnesium delayed-release oral suspension, 20 mg, due to out-of-specification test results for unknown degradation products detected during long-term stability testing.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0361-2025·2025-04-16

    Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity

    Zydus Pharmaceuticals is recalling chlorpromazine hydrochloride 10 mg tablets due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. The recall affects 3,144 bottles distributed nationwide.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0310-2025·2025-04-16

    Venlafaxine Tablets 75 mg Recalled for Foreign Metal Material

    Zydus Pharmaceuticals is recalling Venlafaxine 75 mg tablets due to a complaint of a metal shaving found embedded in a tablet. The recall affects 13,128 bottles distributed nationwide.

    Product
    VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0256-2025·2025-03-12

    Nelarabine prescription injection recalled due to failed quality specifications

    Zydus Pharmaceuticals is recalling 1,893 vials of Nelarabine Injection (250 mg/50 mL) due to failed quality specifications for impurities and degradation. Patients should contact their healthcare provider about the recall.

    Product
    NELARABINE — NELARABINE (NELARABINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0102-2025·2024-12-11

    Prescription drug esomeprazole magnesium recalled for labeling error

    Zydus Pharmaceuticals is recalling esomeprazole magnesium oral suspension because of an incorrect NDC number on package labeling. The affected product is lot M408002 distributed nationwide.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0617-2024·2024-07-31

    Venlafaxine Hydrochloride extended-release capsules recalled for failed dissolution specifications

    Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine Hydrochloride Extended-Release Capsules USP 37.5mg due to failed dissolution specifications in lots M213175 and M213176. The recall affects 13,128 and 252 bottles distributed nationwide.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0600-2024·2024-07-24

    Cyanocobalamin Injection Vials Recalled for Glass Particulate Contamination

    Zydus Pharmaceuticals recalls 432,250 vials of Cyanocobalamin Injection USP due to glass particulate matter. Affected vials are distributed in Tennessee.

    Product
    Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0592-2024·2024-07-17

    Injectable Verapamil Hydrochloride Recalled Due to Cross Contamination Risk

    Zydus Pharmaceuticals is recalling Verapamil Hydrochloride Injection vials nationwide due to potential cross contamination with other products.

    Product
    VERAPAMIL HYDROCHLORIDE — VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0596-2024·2024-07-17

    Micafungin for Injection Recalled for Cross Contamination Risk

    Zydus Pharmaceuticals recalls Micafungin for injection (Lot L300217) distributed nationwide due to potential cross contamination with other products. No illnesses have been reported.

    Product
    Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0593-2024·2024-07-17

    FDA recalls Verapamil Hydrochloride injectable due to cross contamination

    FDA is recalling 8,020 vials of Verapamil Hydrochloride Injection (Lot L300269) distributed nationwide due to potential cross contamination with other products.

    Product
    VERAPAMIL HYDROCHLORIDE — VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0595-2024·2024-07-17

    Micafungin injection vials recalled for cross-contamination

    Zydus Pharmaceuticals is recalling Micafungin for injection (100 mg/vial, Lot #L300220) due to potential cross-contamination with other products. Approximately 12,720 vials distributed nationwide in the USA and Puerto Rico are affected.

    Product
    Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2024·2024-06-12

    Estradiol transdermal patches recalled for failed quality specifications

    Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2024·2024-06-12

    Estradiol Transdermal Patch Recalled for Failed Chemical Specifications

    Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0097-2024·2023-11-15

    Zydus oxybutynin extended-release tablets recalled nationwide for failed stability testing

    Zydus Pharmaceuticals is recalling specific lots of oxybutynin chloride extended-release 10 mg tablets nationwide due to out-of-specification dissolution test results at the 6-month stability timepoint. The affected tablets may not release medication properly.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0098-2024·2023-11-15

    Oxybutynin Extended-Release Tablets Recalled for Failed Dissolution Test Results

    Zydus Pharmaceuticals is recalling Oxybutynin Extended-Release Tablets (15 mg) after dissolution testing showed out-of-specification results at the 6-month mark. No illnesses have been reported.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2024·2023-10-11

    Oxybutynin Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Zydus Pharmaceuticals recalls Oxybutynin Chloride Extended-Release Tablets 10 mg nationwide because the medication failed dissolution specifications. Affected lot numbers: M300652 and M300651.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0467-2023·2023-03-22

    FDA Recalls Colchicine Tablets Due to Failed Impurity Specifications

    Zydus Pharmaceuticals is recalling certain batches of Colchicine Tablets 0.6 mg because quality testing detected out-of-specification levels of Beta-lumicolchicine impurity. Affected lots were distributed in Arizona, Ohio, and Mississippi.

    Product
    Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 7
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-1351-2022·2022-08-24

    Prescription cancer drug lot recalled for failed quality specifications

    Zydus Pharmaceuticals recalls Fulvestrant Injection lot B200076 due to failed purity and stability specifications. Distributed nationwide; expiration January 31, 2024.

    Product
    FULVESTRANT — FULVESTRANT (FULVESTRANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0753-2021·2021-08-25

    Carvedilol Tablets Recalled for Foreign Paroxetine Tablets

    Zydus Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide after Paroxetine tablets were found mixed into bottles. Patients should not take affected bottles and contact their pharmacy or doctor.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide