Food, drugs, devices › Amerisource Health Services LLC
Drug recall: Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packa
FDA enforcement event 97826 is a drug recall by Amerisource Health Services LLC of Columbus, OH, initiated 16 Oct 2025 and classified Class II, with 3 product records.
FDA defines Class II as 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. 79% of the 322 drug enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Amerisource Health Services LLC has 31 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Amerisource Health Services LLC, Columbus, OH.
Reason for recall
"Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit"
Distribution
"Nationwide within the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0101-2026 | Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11 | 1,970 cartons | Class II | Ongoing | 5 Nov 2025 |
| D-0102-2026 | Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11 | 1,818 cartons | Class II | Ongoing | 5 Nov 2025 |
| D-0103-2026 | Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33 | 3,410 cartons | Class II | Ongoing | 5 Nov 2025 |
Context
Other enforcement events for Amerisource Health Services LLC
All 31 events for Amerisource Health Services LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.