FDA recall, , Moderate risk
Cipla Cinacalcet Hydrochloride Tablets
CGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Summary by Recall Canary from the FDA notice
What happened
Cipla USA, Inc., of Warren, New Jersey, recalled Cinacalcet Hydrochloride Tablets in 30 mg, 60 mg, and 90 mg strengths, 30-count bottles, due to cGMP deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). The recall began on June 29, 2026, and was added to the FDA's Enforcement Report on July 2, 2026, with distribution nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Cinacalcet Hydrochloride Tablets
- Strength
- 30 mg
- NDC
- 69097-410-02
- Lot code
- 5PB0465
- 5PB0466
- 5PB0557
- Strength
- 60 mg
- NDC
- 69097-411-02
- Lot code
- 5PB0165
- 5PB0166
- Strength
- 90 mg
- NDC
- 69097-412-02
- Lot code
- 5PB0563
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Cipla USA, Inc.Warren, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99350
- Recall numbers
- D-0661-2026, D-0675-2026, D-0676-2026
All recalls from Cipla USA, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
