Class II U.S. Food and Drug Administration

Amerisource Health Services LLC Prazosin Hydrochloride, Capsules, USP, 1 mg recall: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin

Recall published 12 months ago

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

The hazard: Potency, impurity or stability failure

An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

What the notice says: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0101-2026
Published
November 5, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Amerisource Health Services LLC
Product type
Prescription & OTC drugs
Units affected
1,970 cartons
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 1023526, 1023555, Expiry: 07/31/2026

Products covered by this recall

Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 1023526
  • 1023555

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 07
  • 31
  • 2026 — 1
  • 970 cartons

NDC number

On the carton and again on the bottle or blister label.

  • 68084-996-01
  • 68084-996-11

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Amerisource Health Services LLC — An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  3. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  4. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Amerisource Health Services LLC — 2550 John Glenn Ave Ste A, Columbus, OH, 43217-1188

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Amerisource Health Services LLC prescription & otc drugs recalled?

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 1023526, 1023555; best-by date 07 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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