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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
FDA (Drugs) · 2024-12-11
Same hazard · discoloration
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte 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
Similar recalls
- HighAurobindo Recalls Clozapine Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2020-07-01
- LowAurobindo Recalls Amlodipine and Olmesartan Medoxomil Tablets Due to Discoloration
FDA (Drugs) · 2018-12-12
- SevereAurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- HighLosartan Potassium Tablets Recalled Due to AZIDO Impurity Above Limits
FDA (Drugs) · 2022-05-11
- LowAcetazolamide tablets recalled for discoloration across US distribution
FDA (Drugs) · 2024-09-25
- SevereMacleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity
FDA (Drugs) · 2019-07-17