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

Is NDC 68382-0123-16 recalled?

Amlodipine Besylate · 90 TABLET in 1 BOTTLE (68382-123-16)

Yes — this exact package was recalled

2 FDA recalls name the code 68382-0123-16 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.

Active ingredient
Amlodipine Besylate
Strength
AMLODIPINE BESYLATE 10 mg/1
Form
Tablet · Oral
Labeler
Zydus Pharmaceuticals USA Inc.
Type
Human Prescription Drug
Product code
68382-0123

Recalls naming this package

Class III · Low risk

Amlodipine Besylate Tablets

Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.

Terminated Failed specification Zydus Pharmaceuticals USA Inc NDC 68382-123-16 D-0257-2015
Class II · Moderate risk

amLODIPine BESYLATE

Labeling:Label Mixup; amLODIPine BESYLATE, Tablet, 10 mg may be potentially mislabeled as FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: AD62846_1, EXP: 2/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-726-2014

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