Isotretinoin Capsules Recall by Teva Pharmaceuticals
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Teva Pharmaceuticals is recalling 21,984 packages of Isotretinoin Capsules due to superpotency and subpotency issues, affecting specific lots distributed in Florida, Ohio, Puerto Rico, and Mississippi.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 22, 2026 and geographically references Florida, Ohio, Puerto Rico, and Mississippi. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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Isotretinoin Capsules Recall
What Happened
Teva Pharmaceuticals USA, Inc. is recalling Isotretinoin Capsules because they are superpotent and subpotent, as classified by the FDA in a Class II recall.
Which Products Are Affected
The affected products are Isotretinoin Capsules, USP, 30 mg, Rx Only, in 10 count Prescription Packs. The specific NDC codes are 0591-2435-15 (carton) and 0591-2435-45 (blister pack). A total of 21,984 packages are involved, specifically from lots 100055426 (expiration date 02/2026), 100071518 (expiration date 04/2027), and 100072450 (expiration date 07/2027). These products were distributed in Florida, Ohio, Puerto Rico, and Mississippi.
What You Should Do
Consumers who have the affected Isotretinoin Capsules should follow the initial firm notification, which was issued via letter, for instructions on returns or refunds. Contact Teva Pharmaceuticals USA, Inc. at their address: 400 Interpace Pkwy Bldg A, Parsippany, NJ 07054-1120.
Why This Matters
This recall involves a prescription drug that could affect its safety and effectiveness due to potency issues, potentially impacting thousands of patients in specific U.S. regions.
Source
FDA recall notice D-0445-2026. For more information, visit the FDA website.
Original source: FDA Official Notice ↗
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