HIGH

Biocon Pharma Prazosin Hydrochloride 5mg Recall 28,157 Bottles Over Nitrosamine Impurity (2026)

Biocon Pharma Inc. recalled 28,157 bottles of PRAZOSIN HYDROCHLORIDE capsules, distributed nationwide in the USA. The recall cites cGMP deviation due to detection of N-nitroso-prazosin impurity C above acceptable limits. Stop using the product immediately and contact Appco Pharma LLC or your healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
March 27, 2026
Hazard Level
HIGH
Brands
Prazosin Hydrochloride, Biocon Pharma Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Appco Pharma LLC or your healthcare provider for guidance. Notification method: E-Mail

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About This Product

Prazosin Hydrochloride capsules are prescription medications used to treat high blood pressure and other conditions. They are sold in patient pharmacies and distributed through healthcare channels.

Why This Is Dangerous

The product contains a nitrosamine impurity, N-nitroso-prazosin impurity C, detected above acceptable limits. Nitrosamines are potential carcinogens in long-term exposure.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Consumers may be exposed to a nitrosamine impurity. The recall affects a large number of bottles nationwide and requires immediate cessation of use.

Practical Guidance

How to identify if yours is affected

  1. 1. Check the bottle label for NDC 70377-068-11.
  2. 2. Verify the lot number on the bottle: 2406255UC, 2406256UC, 2407313UC, 2408351UC, 2408352UC, 2509311UC.
  3. 3. Check expiration date on the bottle. If matches listed lots, treat as affected.
  4. 4. Stop using the product if identified as affected.
  5. 5. Contact Appco Pharma LLC or your clinician for guidance and recall updates.

Where to find product info

Label on the bottle and the FDA enforcement recall page linked in the notice.

What timeline to expect

No timeline provided for refunds or replacements in the notice.

If the manufacturer is unresponsive

  • File a complaint with FDA if the company is slow to respond
  • Consult with your healthcare provider for alternative therapies and guidance

How to prevent similar issues

  • For future recalls, always verify NDC numbers and lot codes before dispensing or taking prescription meds
  • Purchase from licensed pharmacies and check for recall notices from the FDA
  • Keep a copy of the recall notice with medication records

Documentation advice

Keep the bottle, labels, recall notice, and any correspondence with the manufacturer. Document purchase date and lot numbers.

Product Details

NDC: 70377-068-11 Bottle count: 100 capsules per bottle Manufactured for: Biocon Pharma Inc., Iselin, NJ Manufactured by: Appco Pharma LLC, Piscataway, NJ Quantity recalled: 28,157 bottles Distribution: USA nationwide Lot numbers: 2406255UC, 2406256UC, 2407313UC, 2408351UC, 2408352UC, 2509311UC Expirations on recalled lots: 2026 May to 2027 Sep (per listed lots)

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 28,157 bottles recalled
  • NDC 70377-068-11
  • Lot numbers: 2406255UC, 2406256UC, 2407313UC, 2408351UC, 2408352UC, 2509311UC
  • Expiration dates span 2026-2027
  • Nationwide distribution in the USA
  • Remedy: stop use and contact manufacturer or clinician

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
POISONING

Product Details

Model Numbers
2406255UC
2406256UC
2407313UC
2408351UC
2408352UC
+1 more
UPC Codes
70377-066
70377-067
70377-068
+3 more
Affected States
ALL
Report Date
April 8, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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