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, PETS
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 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, 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
- Sizes
- 40 mg, 10 count
- 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 is a prescription retinoid used for severe acne. It requires strict medical supervision.
Why This Is Dangerous
Potency variance means dose accuracy can be affected, potentially reducing efficacy or increasing adverse effects.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
No injuries reported yet; patients may experience variable treatment response if potency differs.
Practical Guidance
How to identify if yours is affected
- Check the carton NDC 0591-2436-15.
- Check blister NDC 0591-2436-45.
Where to find product info
Recall page and FDA enforcement notice; packaging labels show NDCs and lot numbers.
What timeline to expect
Refunds or replacements will be communicated by mail letter; processing timelines not specified.
If the manufacturer is unresponsive
- Document contact attempts.
- Escalate to consumer protection agencies if no response.
- Consult your healthcare provider for interim guidance.
How to prevent similar issues
- Verify lot numbers and expiration dates before dispensing.
- Maintain updated patient records with lot tracking.
- Ask pharmacies to verify potency and lot integrity on dispensing.
Documentation advice
Keep recall notification, packaging, and any medical records related to isotretinoin treatment.
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Product Details
Product: Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs. Manufacturer: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. NDC: 0591-2436-15 (carton), 0591-2436-45 (blister). Classification: Class II. Recall number: D-0446-2026. Quantity: 8,376 packages. Distribution: Florida, Ohio, Puerto Rico, Mississippi.
Reported Incidents
No specific injuries or adverse events are reported in the provided data.
Key Facts
- Lots: 100075305 with Exp date 06/2027; 100075512; 100076103 with Exp date 07/2027; other references:
- Exp dates July 2027 for multiple lots
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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