FDA Drug recall D-1207-2019
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Researc…
- FDA Drug
- Class III
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class III recall of Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Researc… by Sun Pharmaceutical Industries, citing subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1207-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-12-07 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
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)
Reason
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Identifiers
| upc | 310631117313 |
|---|---|
| ndc | 10631-115-69 |
| ndc | 10631-115-31 |
| ndc | 10631-116-69 |
| ndc | 10631-116-31 |
| ndc | 10631-117-69 |
| ndc | 10631-117-31 |
| ndc | 10631-118-69 |
| ndc | 10631-118-31 |
| ndc | 10631-133-69 |
| ndc | 10631-133-31 |
| ndc | 10631-134-69 |
| ndc | 10631-134-31 |
| ndc | 10631-002-31 |
| ndc | 10631-003-31 |
| ndc | 10631-004-31 |
| ndc | 10631-005-31 |
| ndc | 10631-006-31 |
| ndc | 10631-007-31 |
| ndc | 3106311173 |
| code_info | Lot: 17F28AA, Exp 1/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Sun Pharmaceutical Industries
- Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., B…
FDA Drug · Class III · 2026-10-14 · Sun Pharmaceutical Industries - Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuti…
FDA Drug · Class III · 2026-10-14 · Sun Pharmaceutical Industries - Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmac…
FDA Drug · Class III · 2026-10-14 · Sun Pharmaceutical Industries - Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262…
FDA Drug · Class II · 2026-08-26 · Sun Pharmaceutical Industries - Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswic…
FDA Drug · Class III · 2026-07-08 · Sun Pharmaceutical Industries
All Sun Pharmaceutical Industries recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1207-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.