Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 bli...

FDA Drug Recall #D-0181-2025 — Class I — November 18, 2024

Recall Summary

Recall Number D-0181-2025
Classification Class I — Serious risk
Date Initiated November 18, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Endo USA, Inc.
Location Malvern, PA
Product Type Drugs
Quantity 22,513 cartons

Product Description

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).

Reason for Recall

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Lot #s: 550145201, Exp. 08/31/2026; 550175901, 550176001, 550176201, Exp. 02/28/2027

Other Recalls from Endo USA, Inc.

Recall # Classification Product Date
D-0527-2026 Class II Buprenorphine Hydrochloride, Injection, 0.3mg/m... Mar 13, 2026
D-0140-2026 Class III Everolimus tablets 7.5mg, 28 tablets (each cart... Oct 10, 2025
D-0142-2026 Class III Everolimus tablets 2.5 mg, 28 tablets (each car... Oct 10, 2025
D-0141-2026 Class III Everolimus tablets 10 mg, 28 tablets (each cart... Oct 10, 2025
D-0139-2026 Class III Everolimus tablets 5mg, 28 tablets (each carton... Oct 10, 2025

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.