Quick Facts at a Glance
- Recall Date
- March 27, 2026
- Hazard Level
- HIGH
- Brands
- Prazosin Hydrochloride, Biocon Pharma
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Product type
- Prazosin Hydrochloride Capsule 2 mg
- Model numbers
- Lot 2404153UC, Exp 2026/MAR, Lot 2404154UC, Exp 2026/MAR, Lot 2502055UC, Exp 2027/JAN, Lot 2505173UC, Exp 2027/MAY +2 more
- UPC codes
- 70377-066, 70377-067, 70377-068, 70377-066-11, 70377-067-11, 70377-068-11
- Sizes
- 2 mg, 100-count bottle
- Sold at
- Unknown
- 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 is a prescription antihypertensive and symptom-management drug. This recall concerns specific lots produced for Biocon Pharma and distributed nationwide in the United States.
Why This Is Dangerous
Nitrosamine impurities in drug substances may pose long-term cancer risk. The impurity detected is N-nitroso-prazosin impurity C (NNP) above acceptable limits due to a cGMP deviation.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Patients using the recalled lots should stop taking the medication and consult their clinician. The recall affects a limited number of bottles but requires action to avoid potential long-term risk.
Practical Guidance
How to identify if yours is affected
- Verify NDC 70377-067-11 on the bottle label.
- Check expiration dates: 2026 MAR for the first two lots; 2027 JAN and 2027 MAY for the latter lots.
- Confirm bottle description: Prazosin Hydrochloride Capsules, USP, 2 mg, 100-count bottle.
Where to find product info
FDA recall page for D-0420-2026 and the enforcement report linked there.
What timeline to expect
No specific refund or replacement timeline is provided in the recall notice.
If the manufacturer is unresponsive
- Document all correspondence with Appco Pharma LLC and your healthcare provider.
- If the company is slow to respond, contact your pharmacist or physician for guidance.
- Report any adverse events to the FDA MedWatch program.
How to prevent similar issues
- Only obtain prescription medications from licensed pharmacies.
- Always verify NDC numbers before dispensing medicines.
- Keep medication packaging intact to preserve recall references.
- Talk to your healthcare provider about alternatives if you require ongoing treatment.
Documentation advice
Keep the bottle, packaging, lot numbers, expiration dates, and all correspondence with the manufacturer or healthcare providers.
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Product Details
Model numbers and lot information below are associated with this recall. NDC 70377-067-11. 58,896 bottles recalled. 100-count bottle. Sold in the USA nationwide. Manufactured for Biocon Pharma Inc., Iselin, NJ. Manufactured by Appco Pharma LLC, Piscataway, NJ.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot 2404153UC Exp 2026/MAR
- Lot 2404154UC Exp 2026/MAR
- Lot 2502055UC Exp 2027/JAN
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Safety Guide
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