Teva Pharmaceuticals USA, Inc. recalls 8,376 isotretinoin 40 mg capsules distributed to FL, OH, PR and MS after FDA enforcement report flags superpotent and subpotent lots. Patients should stop use and contact their healthcare providers for guidance.
Superpotent and Subpotent
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
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Isotretinoin is a prescription retinoid used for severe acne. It requires strict medical supervision.
Potency variance means dose accuracy can be affected, potentially reducing efficacy or increasing adverse effects.
This recall is not part of a broader industry pattern.
No injuries reported yet; patients may experience variable treatment response if potency differs.
Recall page and FDA enforcement notice; packaging labels show NDCs and lot numbers.
Refunds or replacements will be communicated by mail letter; processing timelines not specified.
Keep recall notification, packaging, and any medical records related to isotretinoin treatment.
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.
No specific injuries or adverse events are reported in the provided data.
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