Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0378-5185-93 recalled?

Prasugrel · 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5185-93)

Yes — this exact package was recalled

2 FDA recalls name the code 0378-5185-93 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

1 of these recalls is still ongoing.

Active ingredient
Prasugrel
Strength
PRASUGREL HYDROCHLORIDE 5 mg/1
Form
Tablet, Film Coated · Oral
Labeler
Mylan Pharmaceuticals Inc.
Type
Human Prescription Drug
Product code
0378-5185

Recalls naming this package

Class II · Moderate risk

Prasugrel Tablets

Failed Dissolution Specifications - low dissolution results

Ongoing Dissolution failure Mylan Pharmaceuticals INC NDC 0378-5185-93 D-0280-2025
Class II · Moderate risk

Prasugrel Tablets 5 mg

Failed Dissolution Specification: Low out of specification dissolution results.

Terminated Dissolution failure Mylan Pharmaceuticals Inc. NDC 0378-5185-93 D-0155-2020

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler