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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98275

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 12, 2026
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Teva Pharmaceuticals USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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).

D-0445-2026
Recall number
D-0445-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
21984 packages

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent and Subpotent

Code information

Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027

Distribution pattern

FL, OH, PR & MS

drug · product 2 of 2

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).

D-0446-2026
Recall number
D-0446-2026
Initiated
January 12, 2026
Classification
Class II
Status
Ongoing
Quantity
8376 packages

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent and Subpotent

Code information

Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .

Distribution pattern

FL, OH, PR & MS