Recall archive / FDA company announcement

Par Pharmaceutical: Clonazepam Orally Disintegrating Tablets, USP (C-IV) — FDA announcement Nov 19, 2024

Reported terminated

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 Nov 19, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Clonazepam Orally Disintegrating Tablets, USP (C-IV)
Reason: Mislabeled with the incorrect strength on the carton
Classification: Not supplied
Recalling firm: Endo, Inc.
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: 06509cf27008dee0

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Specifically, Endo’s ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot.; The following table details the lots being added to the voluntary recall, including lot product description and NDC number.; The product is packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number. The packaging lists the legacy company Par Pharmaceutical which previously marketed clonazepam before the product was acquired by Endo.; The images below provide an example of the potential mislabeling showing the components of a package of Clonazepam Orally Disintegrating tablets, USP 2 mg lot 550176501 with a carton bearing the product description and NDC code of Clonazepam Orally Disintegrating Tablets, USP 1 mg 60-count. The location of the lot number on each component of the package is shown on the photographs below.; 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 tablet cartons of Clonazepam Orally Disintegrating tablets, USP bearing the above lot numbers have been advised to discontinue use of the product.; Potential Product Description / NDC Number \| Lot # \| Expiry date; Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02 \| 550176501 \| Feb 2027; 550176601 \| Feb 2027; Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02 \| 550174101 \| Jan 2027; Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02 \| 550142801 \| Aug 2026; 550142901 \| Aug 2026; 550143001 \| Aug 2026; 550143101 \| Aug 2026; 550143201 \| Aug 2026; 550143301 \| Aug 2026; 550143401 \| Aug 2026; 550147201 \| Aug 2026; 550147401 \| Aug 2026; Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02 \| 550145201 \| Aug 2026; 550175901 \| Feb 2027; 550176001 \| Feb 2027; 550176201 \| Feb 2027

Label field

Details supplied by the agency

Lot, code or applicability

Specifically, Endo’s ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot.; The following table details the lots being added to the voluntary recall, including lot product description and NDC number.; The product is packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number. The packaging lists the legacy company Par Pharmaceutical which previously marketed clonazepam before the product was acquired by Endo.; The images below provide an example of the potential mislabeling showing the components of a package of Clonazepam Orally Disintegrating tablets, USP 2 mg lot 550176501 with a carton bearing the product description and NDC code of Clonazepam Orally Disintegrating Tablets, USP 1 mg 60-count. The location of the lot number on each component of the package is shown on the photographs below.; 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 tablet cartons of Clonazepam Orally Disintegrating tablets, USP bearing the above lot numbers have been advised to discontinue use of the product.; Potential Product Description / NDC Number | Lot # | Expiry date; Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02 | 550176501 | Feb 2027; 550176601 | Feb 2027; Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02 | 550174101 | Jan 2027; Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02 | 550142801 | Aug 2026; 550142901 | Aug 2026; 550143001 | Aug 2026; 550143101 | Aug 2026; 550143201 | Aug 2026; 550143301 | Aug 2026; 550143401 | Aug 2026; 550147201 | Aug 2026; 550147401 | Aug 2026; Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02 | 550145201 | Aug 2026; 550175901 | Feb 2027; 550176001 | Feb 2027; 550176201 | Feb 2027

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Potential Product Description / NDC Number	Lot #	Expiry date
Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02	550176501	Feb 2027
Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02	550176601	Feb 2027
Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02	550174101	Jan 2027
Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02	550142801	Aug 2026
	550142901	Aug 2026
	550143001	Aug 2026
	550143101	Aug 2026
	550143201	Aug 2026
	550143301	Aug 2026
	550143401	Aug 2026
	550147201	Aug 2026
	550147401	Aug 2026
Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02	550145201	Aug 2026
	550175901	Feb 2027
	550176001	Feb 2027
	550176201	Feb 2027

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Action Required: The product lots were distributed through wholesale distributors to retail pharmacies nationwide.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Nov 19, 2024
Company announcement date: Nov 21, 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.