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

Is NDC 10631-0117-31 recalled?

Absorica · 3 BLISTER PACK in 1 BOX (10631-117-31) / 10 CAPSULE in 1 BLISTER PACK (10631-117-69)

Yes — this exact package was recalled

1 FDA recall names the code 10631-0117-31 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
isotretinoin
Strength
ISOTRETINOIN 30 mg/1
Form
Capsule · Oral
Labeler
Sun Pharmaceutical Industries, Inc.
Type
Human Prescription Drug
Product code
10631-0117

Recalls naming this package

Class III ยท Low risk

Absorica (Isotretinoin)

Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.

Terminated Wrong potency / content Sun Pharmaceutical Industries, Inc. NDC 10631-117-31 D-1207-2019

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