Pillstats
Rx only · Capsule, Gelatin Coated · Oral

Isotretinoin

Brands: Accutane · Zenatane · Isotretinoin

3 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US12 NDCs
3 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
ATCD10AD04
RxCUI (US)6064
US makers3 labelers
Packages13
DEA / ScheduleNone

US acquisition costNADAC · per unit

Average across 8 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.

$0.585$1.17$1.76$2.34Dec 2025Mar 2026Jul 2026
$1.965
Latest avg · Jul 22, 2026
-2%
Since Dec 17, 2025
3
Active US suppliers
69%
Top-2 supplier share*

Medicaid dispensing volumeSDUD · per quarter

Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.

6.3K13K19K25K2025 Q12025 Q22025 Q32025 Q42026 Q1
21K
Rx · 2026 Q1
993K
Units dispensed
-2%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it3 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Dr.Reddy's laboratories Limitedunknown5SUPPLYING
BluePoint Laboratoriesunknown4SUPPLYING
JG Pharma Inc.unknown4SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • May 22, 2017
    RECALLRecall (Class II): Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By…

    Failed Dissolution Specifications: out of specification results observed for low dissolution. — Recalling firm: Dr. Reddy's Laboratories, Inc. — Nationwide in the USA and Puerto Rico

  • May 22, 2017
    RECALLRecall (Class II): Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By…

    Failed Dissolution Specifications: out of specification results observed for low dissolution. — Recalling firm: Dr. Reddy's Laboratories, Inc. — Nationwide in the USA and Puerto Rico

  • May 22, 2017
    RECALLRecall (Class II): Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By…

    Failed Dissolution Specifications: out of specification results observed for low dissolution. — Recalling firm: Dr. Reddy's Laboratories, Inc. — Nationwide in the USA and Puerto Rico

  • May 22, 2017
    RECALLRecall (Class II): Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By…

    Failed Dissolution Specifications: out of specification results observed for low dissolution. — Recalling firm: Dr. Reddy's Laboratories, Inc. — Nationwide in the USA and Puerto Rico

  • Feb 15, 2017
    RECALLRecall (Class III): Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By…

    Failed dissolution specifications - low dissolution results at S3 stage. — Recalling firm: Dr. Reddy's Laboratories, Inc. — U.S. Nationwide

  • Feb 15, 2017
    RECALLRecall (Class III): Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By…

    Failed dissolution specifications - low dissolution results at S3 stage. — Recalling firm: Dr. Reddy's Laboratories, Inc. — U.S. Nationwide

  • Feb 15, 2017
    RECALLRecall (Class III): Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By…

    Failed dissolution specifications - low dissolution results at S3 stage. — Recalling firm: Dr. Reddy's Laboratories, Inc. — U.S. Nationwide

  • Aug 29, 2016
    RECALLRecall (Class III): ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited,…

    Failed Dissolution Specifications — Recalling firm: Dr. Reddy's Laboratories, Inc. — nationwide