CLASS II ONGOING Drug recall · Reported 5 Nov 2025 · FDA Enforcement Report
Prazosin Hydrochloride, Capsules, USP, 2 mg recalled
Teva Pharmaceuticals USA is recalling Prazosin Hydrochloride, Capsules, USP, 2 mg, distributed nationwide in the US. The recall was initiated on 7 Oct 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-0105-2026
- FDA event ID
- 97755
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Oct 2025
- FDA classified
- 24 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 7 Oct 2025 | Recall initiated by company | |
| 24 Oct 2025 | Classified by FDA | +17 days |
| 5 Nov 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-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
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
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Which lots are affected?
a) NDC 0093-4068-01: Lot # 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, Exp Date: 12/2025; Lot # 3010439A, 3010388A, Exp Date: 01/2026; Lot # 3010526A, 3010527A, Exp Date: 03/2026; Lot # 3010591A, 07/2026; Lot # 3010343A, Exp Date: 10/2025; Lot # 3010352A, Exp Date: 11/2025; Lot # 3010468A, 3010469A, 3010461A, Exp Date: 02/2026; Lot # 3010629A, Exp Date: 09/2026; Lot # 3010653A, Exp Date: 01/2027; Lot # 3010654A, 3010679A, 3010702A, Exp Date: 02/2027; Lot # 3010547A, Exp Date: 04/2026 b) NDC 0093-4068-10: Lot # 3010402A Exp Date: 02/2028; Lot # 3010593A, Exp Date: 07/2026, Lot # 3010610A, Exp Date: 09/2026
Where was it sold?
U.S. Nationwide
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
2 other products · FDA event 97755| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Teva Pharmaceuticals USA | Nitrosamine Impurity | Nationwide | |
| CLASS II | Prazosin Hydrochloride, Capsules, USP, 5 mg recalledPrazosin Hydrochloride | Teva Pharmaceuticals USA | Nitrosamine Impurity | Nationwide |
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Prazosin recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prazosin Hydrochloride Capsules, USP, 5mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride Capsules, USP, 2mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride Capsules, USP, 1mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 5 mg recalledPrazosin Hydrochloride | Teva Pharmaceuticals USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |