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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Prazosin Hydrochloride, Biocon Pharma Inc.
- Product type
- Prazosin Hydrochloride Capsule
- Model numbers
- 2406255UC, 2406256UC, 2407313UC, 2408351UC, 2408352UC, 2509311UC
- UPC codes
- 70377-066, 70377-067, 70377-068, 70377-066-11, 70377-067-11, 70377-068-11
- Sizes
- 100-count bottles
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 27, 2026
Reported by FDA DRUG
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
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
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. Check the bottle label for NDC 70377-068-11.
- 3. Check expiration date on the bottle. If matches listed lots, treat as affected.
- 4. Stop using the product if identified as affected.
- 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.
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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
- Expiration dates span 2026-2027
- Nationwide distribution in the USA
- Remedy: stop use and contact manufacturer or clinician
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Safety Guide
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