The Recall Desk

Manufacturer

Alembic Pharmaceuticals Limited

7 recalls in our database name Alembic Pharmaceuticals Limited as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
2
Most recent
2026-01-14

Of the 7 recalls from Alembic Pharmaceuticals Limited we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (29%) 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.

1–7 of 7

  • HighFDA (Drugs)·D-0566-2025·2025-08-13

    Doxepin hydrochloride capsules exceed the interim nitrosamine impurity limit

    Doxepin Hydrochloride Capsules USP 10 mg from Alembic are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 9,492 bottles affected.

    Product
    DOXEPIN HYDROCHLORIDE — DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2025·2025-06-18

    Celecoxib Capsules 200 mg recalled for foreign tablets inside bottles

    Alembic Pharmaceuticals is recalling Celecoxib 200 mg capsules after a customer found a Tadalafil 5 mg tablet inside a sealed 500-count bottle. The contamination was discovered through a customer complaint.

    Product
    Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0447-2025·2025-06-04

    Bromfenac Ophthalmic Solution 0.09% Recalled for Failed Impurities Specifications

    Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.

    Product
    BROMFENAC OPHTHALMIC SOLUTION 0.09% — BROMFENAC OPHTHALMIC SOLUTION 0.09% (BROMFENAC OPHTHALMIC SOLUTION 0.09%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0326-2021·2021-04-14

    Alembic Pharmaceuticals Recalls Telmisartan Tablets Due to Labeling Error

    Alembic Pharmaceuticals is recalling 12,288 bottles of Telmisartan 20 mg tablets due to a label mixup. The product was distributed nationwide in the United States.

    Product
    TELMISARTAN — TELMISARTAN (TELMISARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1341-2020·2020-07-01

    Alembic Recalls Aripiprazole Tablets Due to Labeling Error

    Alembic Pharmaceuticals is recalling aripiprazole tablets because bottles labeled as 2 mg contained 5 mg tablets. The error affects 19,153 bottles distributed nationwide.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    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.

Alembic Pharmaceuticals Ltd

Indian multinational pharmaceutical company

Country
India
Founded
1907

Official website

Source: Wikidata (Q28451082), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.