Apotex Recalls Cyclosporine Capsules Due to Impurity Failures
Apotex Inc. is recalling 19,584 bottles of Cyclosporine Capsules, USP, 100 mg, because the product failed impurity specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant quality failures like out-of-specification impurities.
Plain-English summary
Apotex Inc. is voluntarily recalling 19,584 bottles of Cyclosporine Capsules, USP, 100 mg, 30 count bottles. The product is identified by Lot MJ9837, with an expiration date of 07/2017, NDC 60505-0134-0, and UPC 360505013401. The capsules were manufactured by Apotex, Inc. in Toronto, Ontario, Canada, for Apotex Corp. in Weston, FL.
The recall was initiated because the product failed impurities and degradations specifications. Specifically, the product yielded out-of-specification results for Maximum Unknown Impurities and Total Impurities. The affected product was distributed nationwide.
Consumers who have this specific lot of Cyclosporine Capsules should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CYCLOSPORINE (CYCLOSPORINE)
- Brand
- CYCLOSPORINE
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 19,584
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 (3)
- Lot MJ9837
- Exp 07/2017. NDC 60505-0134-0
- UPC 360505013401
UPCs (1)
- 360505013401
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CYCLOSPORINE
- ModerateCyclosporine Capsules Recalled for Impurity Specification Failures
FDA (Drugs) · 2017-03-08
Same manufacturer · Apotex Inc.
See all →- SevereApotex Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-06-24
- SevereApotex Recalls Equate Ranitidine Tablets Due to Possible NDMA Contamination
FDA (Drugs) · 2019-11-20
- SevereRite Aid Ranitidine Tablets Recalled for Potential NDMA Contamination
FDA (Drugs) · 2019-11-20
- SevereApotex Recalls Equate Ranitidine Tablets Due to NDMA Contamination
FDA (Drugs) · 2019-11-20
- SevereApotex Recalls Walgreens Wal-Zan 150 Tablets Due to NDMA Contamination Risk
FDA (Drugs) · 2019-11-20
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- ModerateCyclosporine Capsules Recalled for Impurity Specification Failures
FDA (Drugs) · 2017-03-08
- LowPfizer Recalls Cytotec Tablets Due to Failed Impurity Specifications
FDA (Drugs) · 2017-01-18
- LowApotex Recalls Risperidone Oral Solution Due to Impurity Specification Failure
FDA (Drugs) · 2014-05-07
- HighParoxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2023-12-06
- HighAtomoxetine Capsules Recalled for Elevated Nitrosamine Impurity
FDA (Drugs) · 2025-02-26
- ModerateClomipramine capsules failed a degradation product specification at expiry testing
FDA (Drugs) · 2025-07-30