Clorazepate Dipotassium Tablets Recalled Due to Cosmetic Discoloration
Aurobindo Pharma USA Inc. is recalling Clorazepate Dipotassium Tablets 3.75 mg due to yellow dots and discoloration on some tablets distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a cosmetic defect—yellow dots and discoloration on tablets—with no reported health risks, illnesses, or injuries. The purely visual nature of the defect aligns with Score 1 (Low) per the rubric, which designates cosmetic defects as the lowest severity category.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Clorazepate Dipotassium Tablets, USP, 3.75 mg (NDC 13107-282-01 and NDC 13107-282-05) due to discoloration appearing as yellow dots and spots on some tablets.
The recall affects approximately 6,696 bottles distributed nationwide in the United States. Affected lots include CZA124001B, CZA124002B, and CZA124003B (100-tablet bottles), and CZA124001A and CZA124003A (500-tablet bottles), with an expiration date of December 31, 2025.
Consumers who have received affected tablets should stop using them and contact their healthcare provider or pharmacist for a replacement or alternative medication. Bottles should not be disposed of in household trash or flushed; contact a local pharmacy or poison control center for proper disposal instructions.
The recalled product
- Product
- CLORAZEPATE DIPOTASSIUM (CLORAZEPATE DIPOTASSIUM)
- Brand
- CLORAZEPATE DIPOTASSIUM
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug
- Hazard
- Affected units
- 6,696
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #s: a) CZA124001B
- CZA124002B
- CZA124003B
- Exp. 12/31/2025
- b) CZA124001A
- CZA124003A
- Exp. 12/31/2025.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Aurobindo Pharma USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · CLORAZEPATE DIPOTASSIUM
- ModerateClorazepate Dipotassium Tablets Recalled for Tablet Discoloration Defects Nationwide
FDA (Drugs) · 2024-05-15
Same manufacturer · Aurobindo Pharma USA Inc.
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateAmazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration
FDA (Drugs) · 2025-06-25
- HighPrescription drug recall: Aurobindo Nebivolol tablets contain excess nitrosamine impurity
FDA (Drugs) · 2024-12-25
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
FDA (Drugs) · 2024-12-11
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
Same hazard · discoloration
See all →- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModeratePantoprazole Sodium Tablets Recalled for Discoloration Issues
FDA (Drugs) · 2026-04-29