Quick Facts at a Glance
- Recall Date
- March 27, 2026
- Hazard Level
- HIGH
- Brands
- Biocon Pharma, Prazosin Hydrochloride
- 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
- Biocon Pharma, Prazosin Hydrochloride
- Product type
- Prescription Prazosin Hydrochloride Capsules
- Model numbers
- Lot:2404160C, Lot:2406253C, Lot:2407311C, Lot:2407312C, Lot:2408350C, Lot:2505172C, Lot:2506191C
- UPC codes
- 70377-066, 70377-067, 70377-068, 70377-066-11, 70377-067-11, 70377-068-11
- 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 is an antihypertensive prescription medication used to treat high blood pressure and other conditions. The recalled lots are 1 mg, 100-count capsules distributed nationwide in the United States.
Why This Is Dangerous
The recall is due to a cGMP deviation that detected N-nitroso-prazosin impurity C above acceptable limits in the drug substance.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Patients taking these capsules could be exposed to the impurity. Immediate stop-use is advised, and guidance from a healthcare provider is recommended to discuss alternatives.
Practical Guidance
How to identify if yours is affected
- Verify NDC 70377-066-11 on the bottle.
- Check Expiration date: ranges from 2026-03 to 2027-06.
Where to find product info
Refer to the FDA recall page and the recall email notification from Appco Pharma LLC for official instructions.
What timeline to expect
Refunds or replacements, if offered, typically take several weeks after the company processes the recall.
If the manufacturer is unresponsive
- File a consumer complaint with the FDA if the company is unresponsive
- Consult your pharmacist or healthcare provider for alternatives
How to prevent similar issues
- Ask pharmacies to verify NDC and Lot numbers before dispensing medications.
- Monitor recall updates from FDA and the manufacturer.
- If purchasing similar products, ensure they come from verified manufacturers and distributors.
- When buying medications, confirm the supplier is authorized and review recalls before usage.
Documentation advice
Keep the recall notice, email communications, and any correspondence with healthcare providers. Document batch/Lot numbers and dates of purchase.
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Product Details
NDC: 70377-066-11. Product: Prazosin Hydrochloride capsules, USP 1 mg, 100-count bottle (Rx Only). Sold nationwide in the USA. Recall date: 2026-03-27. Quantity: 88,008 bottles. Manufactured for: Biocon Pharma Inc., Iselin, NJ. Manufactured by: Appco Pharma LLC, Piscataway, NJ. Lot numbers and expirations: 2404160C (Exp. 2026-03), 2406253C (Exp. 2026-05), 2407311C (Exp. 2026-07), 2407312C (Exp. 2026-07), 2408350C (Exp. 2026-07), 2505172C (Exp. 2027-05), 2506191C (Exp. 2027-06). Distribution: USA nationwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nitrosamine impurity NN P detected above limits
- Distributed nationwide in the USA
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Safety Guide
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