Alembic Pharmaceuticals recalls

7 official recalls and safety alerts involving Alembic Pharmaceuticals since 2023-08, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Alembic Pharmaceuticals or the relevant agency.

1. 2026-01-14
2. US
   Drugs & medicalClass III

   Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited,…

   Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

   FDA · DrugAlembic Pharmaceuticals LimitedUS Nationwide and PR.Official notice →
3. 2025-11-26
4. US
   Drugs & medicalClass III

   Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals…

   Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

   FDA · DrugAlembic Pharmaceuticals LimitedNationwide in the USA.Official notice →
5. 2025-08-13
6. US
   Drugs & medicalClass II

   Alembic Pharmaceuticals Limited recalls Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v…

   CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

   FDA · DrugAlembic Pharmaceuticals LimitedNationwide in the USA.Official notice →
7. 2025-06-18
8. US
   Drugs & medicalClass II

   Alembic Pharmaceuticals Limited recalls Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division),…

   Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

   FDA · DrugAlembic Pharmaceuticals LimitedDistributed Nationwide and in PROfficial notice →
9. 2025-06-04
10. US
    Drugs & medicalClass II

    Alembic Pharmaceuticals Limited recalls Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc.,…

    Failed Impurities/Degradation Specifications

    FDA · DrugAlembic Pharmaceuticals LimitedUS NationwideOfficial notice →
11. 2023-08-23
12. US
    Drugs & medicalClass III

    ALEMBIC PHARMACEUTICALS, INC. recalls Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921,…

    Failed Impurities/Degradation Specifications

    FDA · DrugALEMBIC PHARMACEUTICALS, INC.Nationwide in the USAOfficial notice →
13. 2023-08-02
14. US
    Drugs & medicalClass II

    ALEMBIC PHARMACEUTICALS, INC. recalls Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals,…

    Defective Delivery System

    FDA · DrugALEMBIC PHARMACEUTICALS, INC.Nationwide within the United StatesOfficial notice →