FDA Drug recall D-1288-2015
Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only by Ranbaxy, citing incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1288-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-26 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ranbaxy |
| Distribution | US |
Product
Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.
Reason
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Identifiers
| 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 |
| code_info | Lot #:14H04AA, Expiry: 02/28/2017. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1288-2015%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.