Class III · Low risk
Lidocaine HCl Injection
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Tirofiban Hydrochloride Injection 5 mg/100 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01
Affected NDC
55150-0429-01
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 |
|---|---|---|---|---|
| Tirofiban NDC 55150-0429 |
HYDROCHLORIDE 5 mg/100mL | Injection, Solution Intravenous |
Eugia US LLC | Rx |
- Recalling firm
- Eugia US LLC
- NDC code
- 55150-429-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0389-2025 · 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 Eugia US LLC
All 2025 recalls
Class II · Moderate risk
Gentamicin Injection
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II · Moderate risk
Tirofiban Hydrochloride Injection 12.5 mg/250 mL
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Other stability / shelf life recalls from 2025
All stability / shelf life recalls
Class II · Moderate risk
Phytonadione Injectable Emulsion
Failed Stability Specifications: Observed OOS results: eg results for colour index
Class II · Moderate risk
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
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