Drug Recall Enforcement Report Class II voluntary initiated by Alembic Pharmaceuticals Limited, originally initiated on 07-25-2025 for the product Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31 The product was recalled due to cgmp deviations: presence of nitrosamine drug substance related impurity above the proposed interim limit.. The product was distributed nationwide and the recall is currently ongoing.
| Field Name |
Field Value |
| Event ID |
97323 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-0566-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification |
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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern |
Nationwide in the USA. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description |
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31 |
| Reason For Recall |
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
9,492 bottles Product Quantity
The amount of product subject to recall. |
| Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date |
08-13-2025 |
| Recall Initiation Date |
07-25-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification |
N/A Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type |
Drugs |
| Recalling Firm |
Alembic Pharmaceuticals Limited |
| Code Info |
Lot: 2305015142, Exp. Date: 9/30/2025 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages |
62332-637-31; 62332-637-91; 62332-638-31; 62332-638-91; 62332-645-31; 62332-645-91; 62332-639-31; 62332-639-91; 62332-640-31; 62332-640-91; 2305015142 |
| Status |
Ongoing |
Recalled Products
