Unrated Drug recall · FDA · Published January 12, 2026

Teva Isotretinoin Capsules Recall: Superpotent and Subpotent Risk

Teva Pharmaceuticals recalls 40mg Isotretretinoin capsules due to superpotent and subpotent risks. Affected lots have specific expiration dates and packaging identifiers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0446-2026Drug Teva ›

Recall notice

Superpotent and Subpotent

Take action

Contact the company

Recalling firmTeva Pharmaceuticals USA, Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120

✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals is recalling 40mg Isotretinoin capsules that may have superpotent or subpotent risks. This recall affects patients taking prescription acne treatment who may need to switch to a different product. Read more at govinfonow.com/recall/31555-teva-isotretinoin-capsules-recall-superpotent-and-subpotent-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31555-teva-isotretinoin-capsules-recall-superpotent-and-subpotent-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0446-2026

Cite this page

“Teva Isotretinoin Capsules Recall: Superpotent and Subpotent Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31555-teva-isotretinoin-capsules-recall-superpotent-and-subpotent-risk. Based on FDA recall #D-0446-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0446-2026%22&limit=1).

The FDA announced on Jan. 12, 2026, that Teva Pharmaceuticals USA, Inc. is recalling Isotretinoin Capsules, USP, 40 mg due to superpotent and subpotent hazards. The voluntary Class II recall affects 8,376 packages distributed in Florida, Ohio, Puerto Rico, and Mississippi.

How to tell if you have it

Brand: Teva
Product: Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs
NDC: 0591-2436-15 (carton), 0591-2436-45 (blister pack)
Lot codes: 100075305 (Exp 06/2027), 100075512 (Exp 07/2027), 100076103 (Exp 07/2027)
Distribution: FL, OH, PR & MS

The hazard

The recall addresses superpotent and subpotent Isotretinoin Capsules. The record does not report specific incidents or injuries associated with this recall.

Context

GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since April 2, 2012. Other recent recalls of similar products include Zydus Icosapent Ethyl Capsules Recall (Dec. 30, 2025), Somerset Therapeutics Cisatracurium Besylate Injection Recall (Nov. 26, 2025), and Ajanta Pharma Fenofibrate Capsules Recall (May 28, 2026).

How to tell if you have this one

Check for the NDC codes 0591-2436-15 (carton) or 0591-2436-45 (blister pack). Look for lot numbers 100075305 (exp 06/2027), 100075512 (exp 07/2027), or 100076103 (exp 07/2027).

Brand
Teva
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
FL, OH, PR & MS
NDC
0591-2433-45, 0591-2433-15, 0591-2434-45, 0591-2434-15, 0591-2451-45, 0591-2451-15, 0591-2435-45, 0591-2435-15, 0591-2501-45, 0591-2501-15, 0591-2436-45, 0591-2436-15

Recall number	Product, codes & lots	Quantity
D-0445-2026	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 pack).; Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027	21984 packages
D-0446-2026	Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).; Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .	8376 packages

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the NDC codes and lot numbers to confirm if your capsules are affected.

Where it went and when

Where it was distributed

Distributed in 3 states and Puerto Rico.

FDA distribution: “FL, OH, PR & MS” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Mississippi, Ohio, Puerto Rico.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jan 12, 2026Firm started the recall
Apr 8, 2026FDA classified it Class II
Apr 15, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31555-teva-isotretinoin-capsules-recall-superpotent-and-subpotent-risk">Teva Isotretinoin Capsules Recall: Superpotent and Subpotent Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0446-2026 (January 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0446-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.