Prazosin Hydrochloride Capsules recall
FDA recall D-0419-2026 · initiated Mar 27, 2026
Appco Pharma LLC recalled Prazosin Hydrochloride Capsules in Mar 2026 — an FDA Class II recall (D-0419-2026) because cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 88,008 bottles- 100's count
Details
- Product
- Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
- Recalling company
- Appco Pharma LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S.A. Nationwide
- Initiated
- Mar 27, 2026
- FDA report date
- Apr 8, 2026
Frequently asked
- Was Prazosin Hydrochloride Capsules recalled?
- Appco Pharma LLC recalled Prazosin Hydrochloride Capsules in Mar 2026 — an FDA Class II recall (D-0419-2026) because cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Prazosin Hydrochloride Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0419-2026 was: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- Is a recalled Prazosin Hydrochloride Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Prazosin Hydrochloride Capsules are affected?
- Distributed: U.S.A. Nationwide. The recall covers these lots — Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0419-2026.