Absorica — Class III drug recall D-1207-2019
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2018-12-26, distributed nationwide. Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing p
| Recall number | D-1207-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2018-12-07 |
| Classified | 2019-04-22 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2019-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 47,520 prescription |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00310631117313 |
| 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 | 17F28AA |
| Expiration dates | 2020-01 |
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 for recall
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
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-1207-2019. 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.