Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Absorica (Isotretinoin) Capsules 30 mg USP Recalled by Sun Pharmaceutical Industries, Inc. Due to Subpotent Drug: Isotretinoin content results were lower than...

Date: December 7, 2018
Company: Sun Pharmaceutical Industries, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sun Pharmaceutical Industries, Inc. directly.

Affected Products

Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)

Quantity: 47,520 prescription packs

Why Was This Recalled?

Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical Industries, Inc. has 40 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report