Desipramine Hydrochloride Tablets recall: Impurity Out of Spec
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India…
Why was Desipramine Hydrochloride Tablets recalled?
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 18035739, Exp. Date: 11/30/2025
- Product
- Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India…
- Recalling firm
- Heritage Pharmaceuticals Inc
- Quantity
- 3,750 bottles.
- Distribution
- U.S. Nationwide.
- Recall date
- November 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)