The Recall Desk

Manufacturer

Hetero Labs Limited (Unit V)

11 recalls in our database name Hetero Labs Limited (Unit V) as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
1
Severe
4
Most recent
2026-04-29

Of the 11 recalls from Hetero Labs Limited (Unit V) we have scored against our rubric, 1 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (36%) 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.

1–11 of 11

  • ModerateFDA (Drugs)·D-0484-2026·2026-04-29

    Pantoprazole Sodium Tablets Recalled for Discoloration Issues

    Hetero Labs Limited is recalling Pantoprazole Sodium 40 mg delayed-release tablets due to discoloration—some tablets are darker than normal with lighter-colored spots. The firm received five complaints about the affected tablets.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1545-2020·2020-09-02

    Hetero Labs Recalls Losartan Potassium Tablets Due to Bulging Complaints

    Hetero Labs is recalling 43,512 bottles of Losartan Potassium 50 mg tablets due to a complaint of bulging tablets.

    Product
    Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0081-2019·2018-10-03

    Hetero Labs Recalls Montelukast Sodium Tablets Due to Labeling Error

    Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because one lot may contain Losartan Potassium 50 mg tablets.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1213-2018·2018-10-03

    Hetero Recalls Montelukast Sodium Tablets Due to Blue Specks

    Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because a pharmacist reported blue specks on the tablets.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1113-2018·2018-08-29

    Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

    Hetero Labs Limited is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1115-2018·2018-08-29

    Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

    Hetero Labs Limited is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1116-2018·2018-08-29

    Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

    Hetero Labs is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1114-2018·2018-08-29

    Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

    Hetero Labs Limited is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0601-2018·2018-03-21

    Valganciclovir Tablets Recalled Due to Temperature Exposure During Shipping

    Hetero Labs Limited is recalling Valganciclovir Tablets 450 mg because they were exposed to high temperatures during shipping. The recall covers 1,764 bottles distributed nationwide.

    Product
    VALGANCICLOVIR — VALGANCICLOVIR (VALGANCICLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0602-2018·2018-03-21

    Hetero Labs Recalls Valacyclovir Tablets Due to Temperature Exposure

    Hetero Labs Limited is recalling Valacyclovir Tablets USP 1 gram because they were exposed to higher temperatures during transport. The recall covers 48,132 bottles distributed nationwide.

    Product
    VALACYCLOVIR — VALACYCLOVIR (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0415-2018·2018-02-21

    Famciclovir Tablets Recalled Due to Temperature Abuse During Distribution

    Hetero Labs Limited is recalling 8,436 bottles of Famciclovir 500 mg tablets because high temperatures during distribution caused the tablets to become wet, stuck together, and disintegrated.

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