Class II U.S. Food and Drug Administration

Amneal Pharmaceuticals of New York, LLC Exenatide Injection, USP, 250 mcg/mL recall: Defective Delivery System: Possibility of no medication in the prefilled pen

Recall published 25 days ago

Defective Delivery System: Possibility of no medication in the prefilled pen.

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: Defective Delivery System: Possibility of no medication in the prefilled pen.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0868-2026
Published
September 30, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Amneal Pharmaceuticals of New York, LLC
Product type
Prescription & OTC drugs
Units affected
5,694 pens
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: AP250095A, Exp 2/28/2027

Products covered by this recall

Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1

Check your product

The notice names 10 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.

  • AP250095A
  • Exp 2
  • 28
  • 2027 — 5
  • 694 pens

Best-by / use-by date

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

  • 28
  • 2027 — 5
  • 694 pens

NDC number

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

  • 70121-1685-1

Package size

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

  • 1.2 mL

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 Drug safety

Amneal Pharmaceuticals of New York, LLC — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Keep the carton; the lot number is often printed only on the outer pack.
  3. Report side effects you think the product caused to FDA MedWatch.
  4. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Amneal Pharmaceuticals of New York, LLC — 50 Horseblock Rd, Brookhaven, NY, 11719-9509

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 Amneal Pharmaceuticals of New York, LLC prescription & otc… recalled?

Defective Delivery System: Possibility of no medication in the prefilled pen. Defective Delivery System: Possibility of no medication in the prefilled pen.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code AP250095A, Exp 2, 28; best-by date 28 or 2027 — 5. 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.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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