CLASS III Drug recall · Reported 20 Nov 2019 · FDA Enforcement Report
Isotretinoin Capsules, USP 10 mg recalled by Amneal Pharmaceuticals
Amneal Pharmaceuticals is recalling Isotretinoin Capsules, USP 10 mg. The recall was initiated on 16 Oct 2019 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-0321-2020
- FDA event ID
- 84073
- Recalling firm
- Amneal Pharmaceuticals, Brookhaven, NY
- Brand
- Isotretinoin
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Oct 2019
- FDA classified
- 13 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 16 Oct 2019 | Recall initiated by company | |
| 13 Nov 2019 | Classified by FDA | +28 days |
| 20 Nov 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
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
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
Where it was distributed
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Which lots are affected?
Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
Where was it sold?
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
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.
More recalls from Amneal Pharmaceuticals
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg, 30-packets recalledEstradiol | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Amneal PharmaceuticalsPrimidone | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Magnesium Sulfate in Water for Injection (40mg/mL) IV recalledMagnesium Sulfate | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalled | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
Other Isotretinoin recalls
All 9| 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 |