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Class II Recall — Risk of Temporary or Reversible Adverse Health Consequences
Verified · FDAClass II — Possible RiskMedications

EXENATIDE Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcuta Recall 2026

EXENATIDEIssued August 28, 2026

EXENATIDE 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; — recalled per FDA on 8/28/2026. Reason: Defective Delivery System: Possibility of no medication in the prefilled pen..

What to do about this recall

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Agency
FDA
Issued
Aug 28, 2026
Brand
EXENATIDE
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

Verified summary of the official U.S. Food and Drug Administration notice · Issued August 28, 2026 · Last synced Oct 12, 2026View on fda.gov

What's recalled

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

Why it was recalled

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

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #: AP250095A
Exp 2/28/2027
Where was it sold
1 state

USA Nationwide

nationwide
View official FDA notice
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the EXENATIDE recall still active?

Yes, this recall is currently active as of August 28, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: AP250095A, Exp 2/28/2027. Check the label on your product.

What should I do if I have the recalled EXENATIDE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.