Clorazepate Dipotassium Tablets recall
FDA recall D-0491-2024 · initiated Apr 24, 2024
Aurobindo Pharma USA Inc. recalled Clorazepate Dipotassium Tablets in Apr 2024 — an FDA Class II recall (D-0491-2024) because Discoloration: Dotted and yellow spots on tablets.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Discoloration: Dotted and yellow spots on tablets
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6696 bottles
Details
- Product
- Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
- Recalling company
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 24, 2024
- FDA report date
- May 15, 2024
Frequently asked
- Was Clorazepate Dipotassium Tablets recalled?
- Aurobindo Pharma USA Inc. recalled Clorazepate Dipotassium Tablets in Apr 2024 — an FDA Class II recall (D-0491-2024) because Discoloration: Dotted and yellow spots on tablets. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Clorazepate Dipotassium Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0491-2024 was: Discoloration: Dotted and yellow spots on tablets
- Is a recalled Clorazepate Dipotassium Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Clorazepate Dipotassium Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0491-2024.