--- title: "Par Pharmaceutical: Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25... — FDA announcement Jul 17, 2024 | Is It on Recall" description: "Mislabeled with the incorrect strength on the carton" url: https://isitonrecall.com/recall/fdapress-de5cc875e995915a-par-pharmaceutical-clonazepam-orally-disintegrating-tablets-usp-c-iv-0-25-mg-tablets/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA company announcement # Par Pharmaceutical: Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets — FDA announcement Jul 17, 2024 Published notice; closure not supplied A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing. Source date Jul 17, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets - **Reason**: Mislabeled with the incorrect strength on the carton - **Classification**: Not supplied - **Recalling firm**: Endo USA, Inc - **Quantity**: Not supplied - **Agency-reported status**: Company recall announcement - **Source record identifier**: de5cc875e995915a [Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp) ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | MALVERN, PA, July 16, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets 60-count pack to the consumer level.; The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg.; Risk Statement: Children and adults who are inadvertently prescribed a two-fold overdose of clonazepam would be at risk for the adverse effects of significant sedation, dizziness, ataxia, and confusion. There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression. To date, Endo has not received any reports of adverse events associated with this product lot recall.; Clonazepam Orally Disintegrating Tablets are indicated alone for as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder. The product is packaged in cartons of 60 tablets; the package labels feature the product name, strength, lot number, and expiration date, and the National Drug Code (NDC) number 49884-307-02; impacted units will display the NDC code 49884-306-02.; This recall impacts the following product lot:; See below image of correct carton label: Clonazepam Orally Disintegrating Tablets, USP 0.25 mg 60-count carton, lot 550147301, expiration date August 2026; See below image of incorrect carton label: Clonazepam Orally Disintegrating Tablets, USP 0.125 mg 60-count carton, lot 550147301, expiration date August 2026; The product lot was distributed through wholesale distributors to retail pharmacies nationwide. Endo is providing written notification to wholesale accounts and retailers that have received product lot 550147301 and is arranging for the return of all existing inventory through Inmar, Inc. Distributors, retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase or contact Inmar on the below telephone line.; Consumers in possession of any unused prescribed 60 tablet cartons of Clonazepam Orally Disintegrating tablets, USP 0.25mg which may also appear as Clonazepam Orally Disintegrating tablets USP 0.125mg bearing the lot number 550147301 have been advised to discontinue use of the product.; This product lot recall is being made with the FDA’s knowledge.; Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including any statements related to the product lot recall, adverse events, regulatory actions by the FDA and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of risks, uncertainties and factors, including risks and uncertainties related to the recall and any future recalls, potential adverse events and any regulatory actions by the FDA. Endo assumes no obligation to publicly update any forward- looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution The product lot was distributed through wholesale distributors to retail pharmacies nationwide. Endo is providing written notification to wholesale accounts and retailers that have received product lot 550147301 and is arranging for the return of all existing inventory through Inmar, Inc. Distributors, retailers that have the product lot being recalled should immediately stop distributing and dispensing and return to the place of purchase or contact Inmar on the below telephone line. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Fda listing date**: Jul 17, 2024 - **Company announcement date**: Jul 16, 2024 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Consumers with questions regarding this recall can contact Inmar by telephone at 877-890- 0765 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at rxrecalls@inmar.com. [Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp) ## Before changing a medicine Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine. Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do) ## Related records [Clonazepam records](https://isitonrecall.com/drug/clonazepam/) [Medications records](https://isitonrecall.com/category/medications/) [Endo USA, Inc. records](https://isitonrecall.com/brand/endo-usa-inc/)