Prazosin hydrochloride further lots recalled over nitrosamine impurity levels
A further quantity of Prazosin Hydrochloride tablets is being recalled after detection of the nitrosamine impurity N-nitroso-prazosin impurity C above acceptable limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a nitrosamine impurity was detected above acceptable limits in a prescription medicine, and no injuries are stated.
Plain-English summary
Prazosin Hydrochloride tablets, in 100-count bottles, are being recalled. About 28,157 bottles were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for a cGMP deviation: detection of a nitrosamine drug substance-related impurity, N-nitroso-prazosin impurity C, above acceptable limits.
Affected lots are listed in the FDA enforcement record.
Patients and pharmacies can identify affected product by the lot numbers printed on the bottle, and may contact the recalling firm for further information.
The recalled product
- Product
- PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Appco Pharma LLC
- Category
- Drug — Prescription tablet
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot:2406255UC
- Exp.: 2026/MAY
- 2406256UC
- Exp.: 2026/JUL
- 2407313UC Exp.: 2026/JUL
- 2408351UC
- 2408352UC
- 2509311UC
- Exp.: 2027/SEP. .
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Appco Pharma LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · PRAZOSIN HYDROCHLORIDE
- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride tablets recalled over nitrosamine impurity above limits
FDA (Drugs) · 2026-04-08
- HighUnit dose prazosin 5 mg cartons recalled over nitrosamine impurity
FDA (Drugs) · 2025-11-05
- HighPrazosin 1 mg capsules recalled over nitrosamine impurity above intake limit
FDA (Drugs) · 2025-11-05
- HighPrazosin 5 mg capsules recalled over nitrosamine impurity above intake limit
FDA (Drugs) · 2025-11-05
Same manufacturer · Appco Pharma LLC
See all →- ModerateVenlafaxine Extended-Release Tablets Recalled for Missing Tablet Identification
FDA (Drugs) · 2025-01-29
- SevereAppco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity
FDA (Drugs) · 2020-01-15
- SevereAppco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity
FDA (Drugs) · 2020-01-15
Same hazard · nitrosamine impurity
See all →- HighEnovachem duloxetine capsules exceed the nitrosamine acceptable intake limit
FDA (Drugs) · 2026-06-10
- HighCipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighAmneal tramadol tablets failed nitrosamine impurity specification at stability
FDA (Drugs) · 2026-04-08