Celecoxib Capsules recall
FDA recall D-0460-2025 · initiated May 13, 2025
AvKARE recalled Celecoxib Capsules in May 2025 — an FDA Class II recall (D-0460-2025) because Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
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: 3,817 50-count cartons
Details
- Product
- Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
- Recalling company
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 13, 2025
- FDA report date
- Jun 18, 2025
Frequently asked
- Was Celecoxib Capsules recalled?
- AvKARE recalled Celecoxib Capsules in May 2025 — an FDA Class II recall (D-0460-2025) because Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules. 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-0460-2025 was: Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
- 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: Nationwide in the USA. The recall covers these lots — Lot #47881, Exp 05/31/2026. 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-0460-2025.