CLASS II Drug recall · Reported 12 Aug 2015 · FDA Enforcement Report
Absorica (isotretinoin) Capsules, 25 mg recalled by Ranbaxy
Ranbaxy is recalling Absorica (isotretinoin) Capsules, 25 mg, distributed nationwide in the US. The recall was initiated on 26 Jun 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1288-2015
- FDA event ID
- 71865
- Recalling firm
- Ranbaxy, Princeton, NJ
- Brand
- Absorica Ld
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jun 2015
- FDA classified
- 6 Aug 2015
- Reported
- 12 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Creams, Ointments & Gels
Timeline
| 26 Jun 2015 | Recall initiated by company | |
| 6 Aug 2015 | Classified by FDA | +41 days |
| 12 Aug 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Absorica (isotretinoin) Capsules, 25 mg recalled?
Yes. Ranbaxy recalled Absorica (isotretinoin) Capsules, 25 mg on 26 Jun 2015. The recall is Class II and its status is Terminated. Recall number D-1288-2015.
Why was it recalled?
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Which lots are affected?
Lot #:14H04AA, Expiry: 02/28/2017.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Isotretinoin recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP 40mg blister packs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |