Teva Recalls Claravis Isotretinoin Capsules Due to Impurity Failures
Teva North America is recalling Claravis (isotretinoin) capsules because they failed impurity and degradation specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific failure of impurity specifications warrants a Moderate rating rather than Low.
Plain-English summary
Teva North America is voluntarily recalling Claravis (isotretinoin capsules USP), 10mg, NDC 00555-1054-86. The recall involves 3,569 capsules from Lot # 34025714A with an expiration date of 12/2016. The product was distributed nationwide.
The recall was initiated because the product failed impurities and degradation specifications. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase for disposal or credit.
The recalled product
- Product
- Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
- Manufacturer
- Teva North America
- Category
- Drug — Prescription Medication
- Affected units
- 3,569
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 34025714A
- Exp. Date 12/2016
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teva North America
See all →- ModerateTeva Recalls Eptifibatide Injection Vials Due to Manufacturing Deviations
FDA (Drugs) · 2016-09-14
- ModerateTeva Recalls Ondansetron Injection Vials Due to Manufacturing Deviations
FDA (Drugs) · 2016-09-14
- ModerateTeva Recalls Argatroban Injection Due to Manufacturing Deviations
FDA (Drugs) · 2016-09-14
- SevereTeva Recalls Linezolid Injection Due to Manufacturing Deviations
FDA (Drugs) · 2016-09-14
- ModerateTeva Recalls Amoxicillin Oral Suspension Due to Potency Issues
FDA (Drugs) · 2016-08-31
Same hazard · impurity failure
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateDigoxin Tablets Recalled Due to Failed Impurity and Degradation Specifications
FDA (Drugs) · 2024-04-24
- HighPrescription Rifampin Capsules Recalled Due to Failed Quality Specifications
FDA (Drugs) · 2023-01-25
- SevereOxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
FDA (Drugs) · 2022-03-16
- LowBausch Health Recalls Mephyton Tablets Due to Impurity D Failure
FDA (Drugs) · 2021-02-03