CLASS III Drug recall · Reported 8 Mar 2017 · FDA Enforcement Report
Zenatane (isotretinoin) capsules, 20 mg recalled
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules, 20 mg, distributed nationwide in the US. The recall was initiated on 15 Feb 2017 and the FDA has classified it as Class III.
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-0507-2017
- FDA event ID
- 76539
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Zenatane
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Feb 2017
- FDA classified
- 2 Mar 2017
- Reported
- 8 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 15 Feb 2017 | Recall initiated by company | |
| 2 Mar 2017 | Classified by FDA | +15 days |
| 8 Mar 2017 | 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
Failed dissolution specifications - low dissolution results at S3 stage.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed dissolution specifications - low dissolution results at S3 stage.
Which lots are affected?
Lot # KB50877, KB50878, Exp 11/17; KB50878, 01KB60251, Exp 3/18
Where was it sold?
U.S. 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 76539This product is part of a recall event; the main page for the event is Zenatane (isotretinoin) capsules, 10 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Zenatane (isotretinoin) capsules, 10 mg recalledZenatane | Dr. Reddy's Laboratories | Potency & Assay | Nationwide | |
| CLASS III | Zenatane (isotretinoin) capsules, 30 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide | |
| CLASS III | Zenatane (isotretinoin) capsules, 40 mg recalledZenatane | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
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 |