CLASS II ONGOING Drug recall · Reported 18 Jun 2025 · FDA Enforcement Report
Celecoxib Capsules, 200 mg recalled by Alembic Pharmaceuticals
Alembic Pharmaceuticals is recalling Celecoxib Capsules, 200 mg, distributed nationwide in the US. The recall was initiated on 9 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0459-2025
- FDA event ID
- 96840
- Recalling firm
- Alembic Pharmaceuticals, Panchmahal
- Brand
- Celecoxib
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 May 2025
- FDA classified
- 6 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Drug class
- Pain Medication
Timeline
| 9 May 2025 | Recall initiated by company | |
| 6 Jun 2025 | Classified by FDA | +28 days |
| 18 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide and in PR
Questions about this recall
Is Celecoxib Capsules, 200 mg recalled?
Yes. Alembic Pharmaceuticals recalled Celecoxib Capsules, 200 mg on 9 May 2025. The recall is Class II and its status is Ongoing. Recall number D-0459-2025.
Why was it recalled?
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Which lots are affected?
Batch 2405014780, Exp. Date: Sep. 30, 2027
Where was it sold?
Distributed Nationwide and in PR
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Alembic Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride | Alembic Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09% | Alembic Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS III | Tobramycin Opthalmic Solution recalled by Alembic PharmaceuticalsTobramycin Ophthalmic Solution | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
Other Celecoxib recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Celecoxib Capsules, 200 mg Unit Dose recalled by AvKARECelecoxib | AvKARE | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Celecoxib USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |