The Recall Desk

Manufacturer

Aurobindo Pharma Limited (Unit I)

1 recall in our database name Aurobindo Pharma Limited (Unit I) as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2018-11-07

Of the 1 recalls from Aurobindo Pharma Limited (Unit I) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) 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.

1–1 of 1

  • SevereFDA (Drugs)·D-0127-2019·2018-11-07

    Aurobindo Recalls Irbesartan Bulk Ingredient Due to Carcinogen Impurity

    Aurobindo Pharma is recalling Irbesartan bulk active ingredient because N-Nitrosodimethylamine (NDEA), a carcinogen, was detected. The product was distributed to one customer in New York.

    Product
    Irbesartan Bulk Active Pharmaceutical Ingredient.
    Category
    Drug
    Distribution
    1 state