FlaggedRx← Medication recall checkHome
Class III · Lower riskRecall completed

Isotretinoin

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberBatch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
Where it was soldRecalled product was distributed to retailers and wholesalers who may have further distribute the product.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals NY LLC
Brand nameISOTRETINOIN
Generic nameISOTRETINOIN
Active ingredient(s)ISOTRETINOIN
Distributed by / forAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
NDC69238-1174-3
Show the full FDA record
Full product labelIsotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
Recalling firmAmneal Pharmaceuticals, Inc.
DistributionRecalled product was distributed to retailers and wholesalers who may have further distribute the product.
Quantity2460 cartons/3 blister cards/10 capsules each
Recall initiated2019-10-16
Report date2019-11-20
Recall completed2020-11-09
Recall numberD-0321-2020
ClassificationClass III
FDA statusTerminated
Origin on fileBrookhaven NY United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.