FDA recall, , Moderate risk
Teva Isotretinoin Capsules
Isotretinoin capsules are superpotent and subpotent.
Summary by Recall Canary from the FDA notice
What happened
Teva Pharmaceuticals USA, Inc., of Parsippany, New Jersey, recalled Isotretinoin Capsules, USP, 40 mg and 30 mg, because they are superpotent and subpotent. The recall began January 12, 2026, and was added to the FDA's Enforcement Report on April 8, 2026. The capsules were distributed in Florida, Ohio, Puerto Rico, and Mississippi.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its lot code and NDC are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
Isotretinoin Capsules, USP
- Strength
- 40 mg
- NDC
- 0591-2436-15
- 0591-2436-45
- Lot code
- 100075305
- 100075512
- 100076103
- Strength
- 30 mg
- NDC
- 0591-2435-15
- 0591-2435-45
- Lot code
- 100055426
- 100071518
- 100072450
Recall details
- Company began the recall
- Sold in
- Company
- Teva Pharmaceuticals USA, IncParsippany, New Jersey
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98275
- Recall numbers
- D-0445-2026 to D-0446-2026
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Teva Pharmaceuticals USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
