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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Isotretinoin Capsules Recalled for Potency Issues

Agency Publication Date: April 8, 2026
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Summary

Teva Pharmaceuticals USA, Inc. is recalling 30,360 packages of Isotretinoin Capsules (the generic version of Accutane) because the medication may be too strong (superpotent) or too weak (subpotent). The recall affects certain 30 mg and 40 mg prescription packs distributed in Florida, Ohio, Puerto Rico, and Mississippi. Using a medication with incorrect potency can lead to either decreased effectiveness in treating severe acne or an increased risk of side effects from taking too much medicine.

Risk

The capsules may contain more or less of the active ingredient than specified on the label. Subpotent medication may fail to treat the underlying condition, while superpotent medication could expose patients to a higher dose of the drug than intended, potentially leading to dose-related adverse effects.

What You Should Do

  1. Check your medication packaging for Isotretinoin Capsules, USP, in 30 mg or 40 mg strengths manufactured for Teva Pharmaceuticals.
  2. For 30 mg capsules, check for NDC 0591-2435-15 (carton) or NDC 0591-2435-45 (blister pack) and lot numbers 100055426, 100071518, or 100072450.
  3. For 40 mg capsules, check for NDC 0591-2436-15 (carton) or NDC 0591-2436-45 (blister pack) and lot numbers 100075305, 100075512, or 100076103.
  4. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Isotretinoin Capsules, USP (30 mg)
Variants: 30 mg, 10 count Prescription Pack
Lot Numbers:
100055426 (Exp. date 02/2026)
100071518 (Exp. date 04/2027)
100072450 (Exp. Date 07/2027)
NDC:
0591-2435-15
0591-2435-45

Recall #: D-0445-2026; Manufactured for Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054.

Product: Isotretinoin Capsules, USP (40 mg)
Variants: 40 mg, 10 count Prescription Pack
Lot Numbers:
100075305 (Exp date 06/2027)
100075512 (Exp date 07/2027)
100076103 (Exp date 07/2027)
NDC:
0591-2436-15
0591-2436-45

Recall #: D-0446-2026; Manufactured for Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98275
Status: Active
Manufacturer: Teva Pharmaceuticals USA, Inc
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (21984 packages; 8376 packages)
Distributed To: Florida, Ohio, Puerto Rico, Mississippi

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.