CLASS II Drug recall · Reported 31 Jan 2024 · FDA Enforcement Report
Cinacalcet Tablets 60mg recalled by Sun Pharmaceutical Industries
Sun Pharmaceutical Industries is recalling Cinacalcet Tablets 60mg, distributed nationwide in the US. The recall was initiated on 18 Jan 2024 and the FDA has classified it as Class II.
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-0263-2024
- FDA event ID
- 93820
- Recalling firm
- Sun Pharmaceutical Industries, Princeton, NJ
- Brand
- Cinacalcet
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 18 Jan 2024
- FDA classified
- 25 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 18 Jan 2024 | Recall initiated by company | |
| 25 Jan 2024 | Classified by FDA | +7 days |
| 31 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Cinacalcet Tablets 60mg recalled?
Yes. Sun Pharmaceutical Industries recalled Cinacalcet Tablets 60mg on 18 Jan 2024. The recall is Class II and its status is Completed. Recall number D-0263-2024.
Why was it recalled?
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Which lots are affected?
Lot #: DNE0702A, Exp. 06/30/2026
Where was it sold?
Nationwide in the USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
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Other Cinacalcet recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |