Clonazepam Orally Disintegrating Tablets recall
FDA recall D-0181-2025 · initiated Nov 18, 2024
Endo USA, Inc. recalled Clonazepam Orally Disintegrating Tablets in Nov 2024 — an FDA Class I recall (D-0181-2025) because Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
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: 22,513 cartons
Details
- Product
- Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).
- Recalling company
- Endo Pharms
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Nov 18, 2024
- FDA report date
- Jan 15, 2025
Frequently asked
- Was Clonazepam Orally Disintegrating Tablets recalled?
- Endo USA, Inc. recalled Clonazepam Orally Disintegrating Tablets in Nov 2024 — an FDA Class I recall (D-0181-2025) because Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Clonazepam Orally Disintegrating Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0181-2025 was: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Is a recalled Clonazepam Orally Disintegrating Tablets 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. Most serious — a reasonable probability that use will cause serious harm or death. 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 Clonazepam Orally Disintegrating Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #s: 550145201, Exp. 08/31/2026; 550175901, 550176001, 550176201, Exp. 02/28/2027. 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-0181-2025.