Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- Agency
- FDA Drug
- Recall date
- Mar 27, 2026
- Status
- Ongoing
- Company
- Appco Pharma LLC
1. What product was recalled?
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc
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.
Quantity: 88,008 bottles- 100's count
Code or lot text: 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.
- LOT
- 2406253C
- LOT
- 2407311C
- LOT
- 2407312C
- LOT
- 2408350C
- LOT
- 2505172C
- LOT
- 2506191C
- LOT
- Exp.: 2027/JUN.
- LOT
- Exp.:2026/JUL
- LOT
- Exp.:2026/MAR
- LOT
- Exp.:2026/MAY
- LOT
- Exp.:2027/MAY
- LOT
- Lot:2404160C
- NDC
- 70377-066
- NDC
- 70377-066-11
- NDC
- 70377-067
- NDC
- 70377-067-11
- NDC
- 70377-068
- NDC
- 70377-068-11
- RECALL-NUMBER
- D-0419-2026
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc
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.
Quantity: 58,896 bottles- 100's count
Code or lot text: Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
- LOT
- 2404154UC
- LOT
- 2502055UC
- LOT
- 2505173UC
- LOT
- 2505175UC
- LOT
- Exp.: 2027/JAN
- LOT
- Exp.: 2027/MAY.
- LOT
- Exp.:2026/MAR
- LOT
- Lot:2404153UC
- NDC
- 70377-066
- NDC
- 70377-066-11
- NDC
- 70377-067
- NDC
- 70377-067-11
- NDC
- 70377-068
- NDC
- 70377-068-11
- RECALL-NUMBER
- D-0420-2026
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.
Quantity: 28,157 bottles- 100's count
Code or lot text: Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .
- LOT
- 2406256UC
- LOT
- 2407313UC Exp.: 2026/JUL
- LOT
- 2408351UC
- LOT
- 2408352UC
- LOT
- 2509311UC
- LOT
- Exp.: 2026/JUL
- LOT
- Exp.: 2026/MAY
- LOT
- Exp.: 2027/SEP. .
- LOT
- Lot:2406255UC
- NDC
- 70377-066
- NDC
- 70377-066-11
- NDC
- 70377-067
- NDC
- 70377-067-11
- NDC
- 70377-068
- NDC
- 70377-068-11
- RECALL-NUMBER
- D-0421-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- updated
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.