Class II · Moderate risk
Methylergonovine Maleate Tablets
Failed Dissolution Specifications
Exenatide Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Delivery System: Possibility of no medication in the prefilled pen.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was 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
Affected NDC
70121-1685-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Exenatide NDC 70121-1685 |
250 ug/mL | Injection Subcutaneous |
Amneal Pharmaceuticals LLC | Rx |
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- NDC code
- 70121-1685-1
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0868-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Amneal Pharmaceuticals of New York, LLC
All 2026 recalls
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Vancomycin Hydrochloride for Oral Solution
Superpotent Drug: Due to overfilling of drug powder
Class II · Moderate risk
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II · Moderate risk
Phenoxybenzamine Hydrochloride Capsules
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Other packaging defect recalls from 2026
All packaging defect recalls
Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Class II · Moderate risk
safco SensiCaine-Ultra
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
PureLife
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Dental City TOPICAL ANESTHETIC GEL
Defective container:may contain bottles with incomplete seals
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