Quick Facts at a Glance
- Recall Date
- January 12, 2026
- Hazard Level
- HIGH
- Brands
- ISOTRETINOIN, Actavis Pharma, Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 4 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ISOTRETINOIN, Actavis Pharma, Inc.
- Product type
- Isotretinoin Capsules
- Model numbers
- Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027
- UPC codes
- 0591-2433, 0591-2434, 0591-2451, 0591-2435, 0591-2501, 0591-2436, 0591-2433-45, 0591-2433-15 +8 more
- Sold at
- Multiple Retailers
- Where affected
- FL, OH, PR, MS
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 12, 2026
Reported by FDA DRUG
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Superpotent and Subpotent
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
About This Product
Isotretinoin capsules are prescribed for severe acne when other treatments fail. The 30 mg dose comes in 10-count prescription packs manufactured for Teva. These are distributed to several states and territories.
Industry Context
This recall is not described as part of a broader safety pattern in the provided data.
Real-World Impact
Patients may need physician oversight to adjust dose. No injuries are reported in the data, but potency inconsistency can result in treatment failure or adverse effects.
Practical Guidance
How to identify if yours is affected
- Check packaging for NDC 0591-2435-15 (carton) or 0591-2435-45 (blister).
Where to find product info
Recall notices and lot-specific guidance are on the FDA enforcement page and Teva recall communications.
What timeline to expect
Refunds or replacements guided by Teva recall communications; typically weeks to months depending on pharmacy/provider processing.
If the manufacturer is unresponsive
- Escalate to the FDA recall contact
- Consult your healthcare provider for guidance and potential alternatives
How to prevent similar issues
- Always verify lot numbers before dispensing or consuming isotretinoin.
- Coordinate with prescriber for dosing adjustments if a potency issue is suspected.
- Use only isotretinoin from trusted manufacturers with active recalls.
Documentation advice
Keep the recall letter, lot numbers, expiration dates, pharmacy records, and any physician communications for your records.
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Product Details
Product: Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack. Manufactured for Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister). Generic: Isotretinoin. Brand: Isotretinoin. Quantity: 21,984 packages. Distribution: FL, OH, PR, MS. Status: Active recall as of 2026-01-12. Company contact: Teva Pharmaceuticals USA, Inc.
Reported Incidents
No specific injuries or incidents are listed in the provided data. The FDA enforcement page notes classification and distribution details, but does not enumerate injuries.
Key Facts
- Lots include 100055426 with exp 02/2026
- Lots include 100071518 with exp 04/2027
- Lots include 100072450 with exp 07/2027
- Distributes to FL, OH, PR, MS
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Safety Guide
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