Class II ยท Moderate risk
Absorica (isotretinoin)
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
National Drug Code
Is NDC 10631-0133-31 recalled?
Absorica · 3 BLISTER PACK in 1 BOX (10631-133-31) / 10 CAPSULE in 1 BLISTER PACK (10631-133-69)
Yes — this exact package was recalled
1 FDA recall names the code 10631-0133-31 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 25 mg/1
- Form
- Capsule · Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Type
- Human Prescription Drug
- Product code
- 10631-0133
Recalls naming this package
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
- 10631-0206 Riomet 3
- 10631-0019 See recall 1
- 10631-0098 See recall 1
- 10631-0099 See recall 1
- 10631-0106 See recall 1
- 10631-0117 Absorica 1
Free recall alerts
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