Teva Pharmaceuticals USA, Inc. recalls 21,984 packages of Isotretinoin Capsules, USP, 30 mg. The lots are distributed to Florida, Ohio, Puerto Rico and Mississippi. The recall is active as of April 15, 2026.
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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 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.
Potency variations can lead to underdosing or overdosing, impacting safety and efficacy. Serious birth defects risk remains for pregnant patients exposed to isotretinoin.
This recall is not described as part of a broader safety pattern in the provided data.
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.
Recall notices and lot-specific guidance are on the FDA enforcement page and Teva recall communications.
Refunds or replacements guided by Teva recall communications; typically weeks to months depending on pharmacy/provider processing.
Keep the recall letter, lot numbers, expiration dates, pharmacy records, and any physician communications for your records.
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.
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.
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