Absorica — Class II drug recall D-1288-2015
Terminated recall by Ranbaxy Inc., reported 2015-08-12, distributed nationwide. Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
| Recall number | D-1288-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ranbaxy Inc., Princeton, NJ, United States |
| Recall initiated | 2015-06-26 |
| Classified | 2015-08-06 |
| Reported by FDA | 2015-08-12 |
| Terminated | 2016-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 9,229 boxes |
| Reason classes | undeclared allergen |
| NDC | 10631-0002, 10631-0002-31, 10631-0003, 10631-0003-31, 10631-0004, 10631-0004-31, 10631-0005, 10631-0005-31, 10631-0006, 10631-0006-31, 10631-0007, 10631-0007-31, 10631-0115, 10631-0115-31, 10631-0115-69, 10631-0116, 10631-0116-31, 10631-0116-69, 10631-0117, 10631-0117-31, 10631-0117-69, 10631-0118, 10631-0118-31, 10631-0118-69, 10631-0133 and 5 more |
| Lot numbers | 14H04AA |
| Expiration dates | 2017-02-28 |
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 for recall
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1288-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.