Agency: Food and Drug Administration (FDA) | Date: 20260311 | Units: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules | Risk: Class III
This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 6, 2026.
Stock photo for illustration — not the actual recalled product. Photo by Zulfugar Karimov on Unsplash
Stop taking those pills.
Cipla USA, Inc. has issued a voluntary recall for Nilotinib Capsules, a prescription medication, due to failed tablet specifications. This product recall in the United States affects capsules manufactured by Cipla Ltd. and distributed nationwide. If you're currently taking this medication, read on to determine if your supply is affected and what steps you should take.
Background on Nilotinib Capsules
Nilotinib Capsules are a prescription medication typically used to treat certain types of leukemia. It's available only with a prescription from your doctor. Cipla USA, Inc. manufactures and distributes these capsules in the United States. The capsules are packaged in cartons, with each capsule containing 150 mg of Nilotinib.
The Reason for the Recall: Failed Tablet Specifications
The reason for this product recall is due to “Out Of Specification” (OOS) results observed during a 6-month long-term stability test. Specifically, the description and appearance of the capsules failed the visual inspection test, based on the official recall notice. This means the capsules may not meet the required quality standards for the medication. The agency confirmed that this issue could potentially impact the drug's effectiveness or safety. This is considered a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Which Products Are Affected?
This recall affects the following Nilotinib Capsules:
- Product: Nilotinib Capsules, 150 mg per capsule, Rx only
- Manufactured by: Cipla Ltd., Verna, Goa, India
- Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
- Outer carton: 112 capsules (4 individual packs containing 28 capsules each)
- NDC (Outer Carton): 69097-031-74
- Inner carton: 28 capsules (4 blisters of 7 capsules)
- NDC (Inner Carton): 69097-031-56
- Foil blister: NDC 69097-031-17
- Lot Numbers: 5GJ0220, 5GJ0221, 5GJ0222
- Expiration Date: 04/30/2027
A total of 271 cartons are affected by this recall. This breaks down to 84 outer cartons, each containing 4 inner cartons, with each inner carton containing 4 blisters, and each blister containing 7 capsules. The affected products were sold across the U.S., so American shoppers should check their medication. If you flip the product over, you'll find the relevant lot numbers.
What To Do Right Now
Nobody wants to find out their medication is part of a recall. Here's what you should do if you have Nilotinib Capsules with the affected lot numbers:
- Immediately check your Nilotinib Capsules to see if the lot number matches those listed above (5GJ0220, 5GJ0221, or 5GJ0222).
- If your medication is from one of the recalled lots, stop using it immediately.
- Contact your healthcare provider or pharmacist to discuss alternative treatment options and to obtain a replacement prescription if necessary. Let them know about this Cipla USA recall.
- Contact Cipla USA, Inc. directly for information on how to return the recalled medication or for other instructions related to the recall.
Potential Health Risks
As a Class III recall, the FDA states that this recall is unlikely to cause adverse health consequences. However, taking medication that doesn't meet quality standards could affect your treatment. It's best to err on the side of caution and consult your doctor as soon as possible. Make sure to tell your doctor that the product was recalled due to failed tablet specifications, including issues with the description and visual appearance of the capsules. Although it's a Class III recall, it's always best to protect your health.
Cipla USA Recall History
Cipla USA, Inc. has had previous recalls, so it's important for U.S. consumers to stay informed about potential issues with their products. While this recall is specifically for Nilotinib Capsules, being aware of a company's history can help you make informed decisions about your healthcare. Recalls happen, and it's better to be prepared. The FDA has issued dozens of recalls in 2026 already, so this situation is not unique.
Frequently Asked Questions
Q: Why are the Nilotinib Capsules being recalled?
The Nilotinib Capsules are being recalled because they failed to meet quality standards during stability testing, specifically regarding their description and appearance.
Q: What does "OOS" mean in the recall notice?
"OOS" stands for "Out Of Specification." It means the product did not meet the required specifications during testing.
Q: What should I do if I took one of the recalled capsules?
Contact your healthcare provider to discuss your concerns and explore alternative treatment options to ensure your health is not compromised.
Q: Where can I find the lot number on my Nilotinib Capsules?
The lot number can be found on the outer carton, inner carton, and on the foil blister pack of the capsules. Make sure to check all packaging components.
Q: Will I get a refund for my recalled Nilotinib Capsules?
Contact Cipla USA, Inc. directly to inquire about their refund or replacement policies related to this recall. They will provide you with the necessary instructions.
This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.
Stop using it right away and follow the steps above. You may be entitled to a full refund, free repair, or replacement at no cost.