CLASS II ONGOING Drug recall · Reported 15 May 2024 · FDA Enforcement Report
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) recalled
Aurobindo Pharma USA is recalling Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) per, distributed nationwide in the US. The recall was initiated on 24 Apr 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0492-2024
- FDA event ID
- 94500
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Manufacturer
- Aurolife Pharma LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Apr 2024
- FDA classified
- 8 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 24 Apr 2024 | Recall initiated by company | |
| 8 May 2024 | Classified by FDA | +14 days |
| 15 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Dotted and yellow spots on tablets
Product as listed by the FDA
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Discoloration: Dotted and yellow spots on tablets
Which lots are affected?
Lot #s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94500| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) recalledClorazepate Dipotassium | Aurobindo Pharma USA | Other | Nationwide |
More recalls from Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
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| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
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Other Clorazepate Dipotassium recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) recalledClorazepate Dipotassium | Aurobindo Pharma USA | Other | Nationwide |