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.
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 4
Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81
Potency or specification failurereason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Failed dissolution specifications - low dissolution results at S3 stage.
Code information
Lot # 01KB60250, Exp 3/18
Distribution pattern
U.S. Nationwide
drug · product 2 of 4
Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
Potency or specification failurereason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Failed dissolution specifications - low dissolution results at S3 stage.
Code information
Lot # KB50877, KB50878, Exp 11/17; KB50878, 01KB60251, Exp 3/18
Distribution pattern
U.S. Nationwide
drug · product 3 of 4
Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81
Potency or specification failurereason.potency_specification_failure · v1.0.0
Failed dissolution specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Failed dissolution specifications - low dissolution results at S3 stage.
Code information
Lot # KB60036, Exp 12/17
Distribution pattern
U.S. Nationwide
drug · product 4 of 4
Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
