Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated May 9, 2025 (17 months ago)

Celecoxib Capsules

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

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

Affected NDC 62332-0142-71

Compare with the code on your package — it is the most precise check available.

Drug: Celecoxib

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Celecoxib
NDC 62332-0142
200 mg/1 Capsule
Oral
Alembic Pharmaceuticals Inc. Rx
Recalling firm
Alembic Pharmaceuticals Limited
NDC code
62332-142-71
Origin
India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0459-2025 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Celecoxib recalls

See all
Class II · Moderate risk

Celecoxib Capsules

Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

Ongoing Particulate / foreign matter AvKARE NDC 50268-169-15 D-0460-2025
Class II · Moderate risk

Celecoxib USP for prescription compounding

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Terminated Stability / shelf life American Pharmaceutical Ingredients LLC NDC 58597-8635-4 D-0478-2018
Class II · Moderate risk

Celecoxib active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-570-2015

Other recalls by Alembic Pharmaceuticals Limited

All 2025 recalls
Class II · Moderate risk

Bromfenac Ophthalmic Solution 0.07%

Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.

Ongoing Impurity / degradation Alembic Pharmaceuticals, INC. NDC 62332-583-03 Recall number pending
Class III · Low risk

Fesoterodine Fumarate

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

Ongoing Impurity / degradation Alembic Pharmaceuticals Limited NDC 62332-176-30 D-0248-2026
Class III · Low risk

Fesoterodine Fumarate

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

Ongoing Impurity / degradation Alembic Pharmaceuticals Limited NDC 62332-175-30 D-0156-2026
Class II · Moderate risk

Doxepin Hydrochloride Capsules

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

Ongoing Nitrosamine impurity Alembic Pharmaceuticals Limited NDC 62332-637-31 D-0566-2025