The Recall Desk

Manufacturer

Unichem Pharmaceuticals USA Inc.

12 recalls in our database name Unichem Pharmaceuticals USA Inc. as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
1
Severe
0
Most recent
2026-05-13

Of the 12 recalls from Unichem Pharmaceuticals USA Inc. we have scored against our rubric, 1 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–12 of 12

  • LowFDA (Drugs)·D-0511-2026·2026-05-13

    Buspirone Hydrochloride Tablets 5 mg Recalled for Subpotency

    Unichem Pharmaceuticals USA Inc. is recalling Buspirone Hydrochloride Tablets, USP, 5 mg because the drug is subpotent. The recall affects approximately 10,875 bottles distributed nationwide.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0301-2026·2026-02-11

    Bisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity

    Unichem Pharmaceuticals USA is recalling a lot of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, for not meeting the N-Nitroso Bisoprolol impurity specification limits.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0655-2025·2025-09-24

    Cyclobenzaprine bottles recalled after being filled with meloxicam tablets instead

    Unichem Cyclobenzaprine Hydrochloride Tablets, 10 mg, lot GMML24026A, are recalled because bottles labeled as cyclobenzaprine contained yellow Meloxicam 7.5 mg tablets. The FDA classified the action as Class I.

    Product
    CYCLOBENZAPRINE HYDROCHLORIDE — CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1541-2022·2022-09-28

    Clonidine Hydrochloride 0.3 mg Tablets Recalled for Strength Mix-up

    UNICHEM PHARMACEUTICALS is recalling Clonidine Hydrochloride Tablets labeled 0.3 mg that contain 0.2 mg tablets instead. The recall affects 18,960 bottles (Lot # GCLH22005) distributed nationwide.

    Product
    CLONIDINE HYDROCHLORIDE — CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0255-2022·2021-12-01

    Topiramate 50 mg tablets recalled due to discoloration

    Unichem Pharmaceuticals USA Inc is recalling Topiramate 50 mg tablets nationwide due to discoloration. The affected lot is ZTPM20044, expiring 09/30/2022.

    Product
    TOPIRAMATE — TOPIRAMATE (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0829-2020·2020-02-12

    Unichem Recalls Clonidine Hydrochloride Tablets Due to Benzophenone Migration

    Unichem Pharmaceuticals is recalling Clonidine Hydrochloride tablets due to potential benzophenone migration from container labels. This is a precautionary measure.

    Product
    CLONIDINE HYDROCHLORIDE — CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2018·2018-01-24

    Unichem Recalls Divalproex Sodium Tablets Due to Metronidazole Contamination

    Unichem Pharmaceuticals is recalling Divalproex Sodium tablets because metronidazole powder was found in one bottle. The product was distributed nationwide.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0010-2018·2017-10-25

    Unichem Recalls Bisoprolol Fumarate Tablets Due to Stability Impurity

    Unichem Pharmaceuticals is recalling 96,876 bottles of Bisoprolol Fumarate 5 mg tablets because stability testing revealed an out-of-specification unknown impurity.

    Product
    BISOPROLOL FUMARATE — BISOPROLOL FUMARATE (BISOPROLOL FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1519-2016·2016-10-05

    Unichem Recalls Lamotrigine Tablets With Incorrect Imprint

    Unichem Pharmaceuticals is recalling 368 bottles of Lamotrigine 150 mg tablets because they have the wrong imprint. The FDA classifies this as Class III.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1352-2015·2015-09-02

    Unichem Recalls Hydrochlorothiazide Tablets Due to Foreign Tablet Presence

    Unichem Pharmaceuticals is recalling 4,776 bottles of hydrochlorothiazide 25 mg tablets because a pharmacist found a clopidogrel tablet in one bottle.

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