CLASS II ONGOING Drug recall · Reported 8 Apr 2026 · FDA Enforcement Report
Prazosin Hydrochloride Capsules, USP, 2mg recalled by Appco Pharma
Appco Pharma is recalling Prazosin Hydrochloride Capsules, USP, 2mg, distributed nationwide in the US. The recall was initiated on 27 Mar 2026 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-0420-2026
- FDA event ID
- 98658
- Recalling firm
- Appco Pharma, Piscataway, NJ
- Manufacturer
- Biocon Pharma Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Mar 2026
- FDA classified
- 31 Mar 2026
- Reported
- 8 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 27 Mar 2026 | Recall initiated by company | |
| 31 Mar 2026 | Classified by FDA | +4 days |
| 8 Apr 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
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, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Prazosin Hydrochloride Capsules, USP, 2mg recalled?
Yes. Appco Pharma recalled Prazosin Hydrochloride Capsules, USP, 2mg on 27 Mar 2026. The recall is Class II and its status is Ongoing. Recall number D-0420-2026.
Why was it recalled?
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Which lots are affected?
Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
Where was it sold?
U.S.A. 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 21 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 Appco Pharma
All 6| 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, 1mg recalled by Appco PharmaPrazosin Hydrochloride | Appco Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Venlafaxine Extended-Release Tablets, 150mg recalled by Appco PharmaVenlafaxine | Appco Pharma | Other | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 150 mg, (a) bottles recalled by Appco Pharma | Appco Pharma | Nitrosamine Impurity | NJ |
| Drug | CLASS II | Ranitidine Capsules 300 mg recalled by Appco Pharma | Appco Pharma | Nitrosamine Impurity | NJ |
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, 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 |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 2 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |