CLASS II ONGOING Drug recall · Reported 13 Aug 2025 · FDA Enforcement Report
Doxepin Hydrochloride Capsules, USP, 10 mg recalled
Alembic Pharmaceuticals is recalling Doxepin Hydrochloride Capsules, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 25 Jul 2025 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-0566-2025
- FDA event ID
- 97323
- Recalling firm
- Alembic Pharmaceuticals, Panchmahal, N/A
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jul 2025
- FDA classified
- 1 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Nitrosamine Impurity
Timeline
| 25 Jul 2025 | Recall initiated by company | |
| 1 Aug 2025 | Classified by FDA | +7 days |
| 13 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Which lots are affected?
Lot: 2305015142, Exp. Date: 9/30/2025
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.
More recalls from Alembic Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Celecoxib Capsules, 200 mg recalled by Alembic PharmaceuticalsCelecoxib | Alembic Pharmaceuticals | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09% | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Tobramycin Opthalmic Solution recalled by Alembic PharmaceuticalsTobramycin Ophthalmic Solution | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
Other Doxepin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Doxepin HCL Capsule, 150 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |