Lower risk Drug recall · FDA · Published December 7, 2018

Sun Pharmaceutical Absorica 30mg Capsules Recall: Subpotent Drug Risk

Sun Pharmaceutical recalls Absorica 30mg capsules due to lower-than-stated isotretinoin content. Affected lots may pose reduced effectiveness risks. Contact for return instructions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1207-2019Drug Sun Pharmaceutical ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmSun Pharmaceutical Industries, Inc.270 Prospect Plains Rd · Cranbury, NJ 08512-3605

✎ GovInfoNow plain-language explainer

Sun Pharmaceutical is recalling Absorica 30mg capsules because they contain less isotretinoin than specified. This could mean the medication isn't as effective as it should be for treating severe acne. Read more at govinfonow.com/recall/39380-sun-pharmaceutical-absorica-30mg-capsules-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39380-sun-pharmaceutical-absorica-30mg-capsules-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1207-2019

Cite this page

“Sun Pharmaceutical Absorica 30mg Capsules Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39380-sun-pharmaceutical-absorica-30mg-capsules-recall-subpotent-drug-risk. Based on FDA recall #D-1207-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1207-2019%22&limit=1).

The FDA announced on 2018-12-07 that Sun Pharmaceutical Industries Inc. voluntarily recalled Absorica (Isotretinoin) Capsules due to subpotent drug content, according to the FDA.

How to tell if you have it

Brand: Sun Pharmaceutical
Product: Absorica (Isotretinoin) Capsules 30 mg USP
Pack size: 30 capsules (3x10 Prescription Packs)
Manufacturer: Galephar Pharmaceutical Research Inc.
UPC: 00310631117313
NDC (carton): 10631-117-31
NDC (prescription pack): 10631-117-69
Lot code: 17F28AA
Expiration date: 1/2020
Distribution: Nationwide in the USA

The hazard

Isotretinoin content results were lower than the specification limit obtained during routing product monitoring, according to the FDA.

Context

GovInfoNow's records show SUN PHARMACEUTICAL INDUSTRIES INC has 93 other recalls on record since 2013-05-21. Other recent recalls include Tretinoin Cream (2026-09-25), Carbamazepine Tablets (2026-08-03), and Perampanel 6mg Tablets (2026-06-17). Similar recent recalls of isotretinoin products include Teva Isotretinoin Capsules (2026-01-12) and Mylan Amnesteem Isotretinoin Capsules (2026-02-24).

How to tell if you have this one

Check for the lot number 17F28AA on the packaging. The product was distributed with UPC 310631117313 and NDC 10631-117-31 (carton) or NDC10631-117-69 (prescription pack).

Brand
Sun Pharmaceutical
Product
Sun Pharmaceutical Industries, Inc. recalls Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number 17F28AA on the packaging to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 6 months after the firm started it.

Dec 7, 2018Firm started the recall
Dec 26, 2018Published in FDA’s Enforcement Report
Apr 22, 2019FDA classified it Class III
Jun 14, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Sun Pharmaceutical recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/39380-sun-pharmaceutical-absorica-30mg-capsules-recall-subpotent-drug-risk">Sun Pharmaceutical Absorica 30mg Capsules Recall: Subpotent Drug Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1207-2019 (December 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1207-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.