Celecoxib Capsules recall
FDA recall D-0459-2025 · initiated May 9, 2025
Alembic Pharmaceuticals Limited recalled Celecoxib Capsules in May 2025 — an FDA Class II recall (D-0459-2025) because Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,946 500-count bottles
Details
- 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
- Recalling company
- Alembic Pharms Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide and in PR
- Initiated
- May 9, 2025
- FDA report date
- Jun 18, 2025
Frequently asked
- Was Celecoxib Capsules recalled?
- Alembic Pharmaceuticals Limited recalled Celecoxib Capsules in May 2025 — an FDA Class II recall (D-0459-2025) because Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Celecoxib Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0459-2025 was: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
- Is a recalled Celecoxib Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Celecoxib Capsules are affected?
- Distributed: Distributed Nationwide and in PR. The recall covers these lots — Batch 2405014780, Exp. Date: Sep. 30, 2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0459-2025.