Teva Pharmaceuticals Recalls Isotretinoin Capsules Over Potency Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Teva Pharmaceuticals is voluntarily recalling 8,376 packages of Isotretinoin Capsules due to potential superpotency or subpotency issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 22, 2026 and geographically references United States (FL, OH, PR, MS). 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Drugs.
What Happened
Teva Pharmaceuticals USA, Inc. is recalling Isotretinoin Capsules because they may be superpotent or subpotent, which could affect their safety and effectiveness.
Which Products Are Affected
The affected products are Isotretinoin Capsules, USP, 40 mg, in 10 count Prescription Pacs, Rx only. The NDC numbers are 0591-2436-15 (carton) and 0591-2436-45 (blister pack). A total of 8,376 packages are involved, specifically from lots 100075305 with expiration date 06/2027, 100075512 with expiration date 07/2027, and 100076103 with expiration date 07/2027. These products were distributed to FL, OH, PR, and MS.
What You Should Do
Consumers should contact Teva Pharmaceuticals USA, Inc. at their address, 400 Interpace Pkwy Bldg A, Parsippany, NJ 07054-1120, for instructions on returning the affected products, as the recall was initiated via letter.
Why This Matters
This recall involves a prescription drug that could impact patient health if the potency is incorrect, affecting thousands of packages in specific U.S. regions.
Source
FDA recall notice D-0446-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,097 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 22, 2026.
Frequently Asked Questions
Common questions about this FDA recall.