Prazosin hydrochloride tablets recalled over nitrosamine impurity above limits
Five lots of Prazosin Hydrochloride tablets are 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 58,896 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 product covers lots 2404153UC and 2404154UC (expiry March 2026), 2502055UC (expiry January 2027), and 2505173UC and 2505175UC (expiry May 2027).
Patients and pharmacies can identify affected product by the lot numbers and expiry dates above, 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 (10)
- Lot:2404153UC
- Exp.: 2026/MAR
- 2404154UC
- Exp.:2026/MAR
- 2502055UC
- Exp.: 2027/JAN
- 2505173UC
- Exp.: 2027/MAY
- 2505175UC
- Exp.: 2027/MAY.
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
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