FDA drug recalls · openFDA
Is CINACALCET recalled?
The FDA has recorded 17 recalls of CINACALCET (2024–2026) , recalled under brand like CINACALCET. 17 still ongoing.
0
Class I (most serious)
17
Class II
0
Class III
17
ongoing
A recall doesn't mean your pills are affected
Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of CINACALCET ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.
Why it was recalled
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) l 6
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit 3
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit 3
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit 3
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. 1
The recalls
Class I and ongoing recalls first. Tap a recall for its full record and lot detail.
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, Class II ongoing
Cipla USA, Inc. 2026-03-16 lots: Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, Class II ongoing
Cipla USA, Inc. 2026-03-16 lots: Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, Class II ongoing
Cipla USA, Inc. 2026-03-16 lots: Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe Class II ongoing
Cipla USA, Inc. 2025-11-14 lots: Lot 5PB0183, exp 1/31/2027
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe Class II ongoing
Cipla USA, Inc. 2025-11-14 lots: Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe Class II ongoing
Cipla USA, Inc. 2025-11-14 lots: Lot 5PB0164, exp 1/31/2027
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Dis Class II ongoing
Strides Pharma, Inc. 2025-07-09 lots: Lot #: 7715893A, Exp. Date 12/31/2027
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-8 Class II ongoing
Aurobindo Pharma USA Inc 2024-11-07 lots: Lot #: a) CFSB23001A, Exp 03/31/2025, CFSB23002A, Exp 07/31/2025; CFSB23003A, Exp 10/31/2025; CFSB23004A, Exp 10/31/2025; b) P2300196, 12/31/2024
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862- Class II ongoing
Aurobindo Pharma USA Inc 2024-11-07 lots: Lot #: a) CFSA23001A, CFSA23002A, CFSA23003A, Exp 03/31/2025; CFSA23004A, Exp 07/31/2025; CFSA23005A, Exp 10/31/2025; b) P2300191, P2300192, P2300193, P2300194, Exp 12/31/2024
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, Class II Completed
SUN PHARMACEUTICAL INDUSTRIES INC 2024-01-18 lots: Lot #: DNE0702A, Exp. 06/30/2026
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-44 Class II ongoing
ACCORD HEALTHCARE, INC. 2024-10-10 lots: a) Lot #: Expiry Date: M2303264 01/2026 b) Lot #: Expiry Date: M2306979 04/2026
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., Class II ongoing
Dr. Reddy's Laboratories, Inc. 2024-10-09 lots: Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-44 Class II ongoing
ACCORD HEALTHCARE, INC. 2024-10-10 lots: a) Lot #: Expiry Date: M2204481 02/2025 M2212389 08/2025 M2214271 09/2025 M2215970 10/2025 M2216458 10/2025 b) Lot #: Expiry Date: M2212869 08/2025 M2216362 09/2025 M2215969 10/2025
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, Class II ongoing
Dr. Reddy's Laboratories, Inc. 2024-10-09 lots: Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026.
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862- Class II ongoing
Aurobindo Pharma USA Inc 2024-11-07 lots: Lot #: a) CFSC23001A, CFSC23001B, Exp 03/31/2025; b) P2300195, Exp 12/31/2024
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440 Class II ongoing
ACCORD HEALTHCARE, INC. 2024-10-10 lots: a) Lot #: Expiry Date: M2118190 11/2024 M2201091 11/2024 M2206241 11/2024 M2206451 04/2025 M2208674 06/2025 M2213850 08/2025 M2215221 09/2025 M2216236 11/2025 M2217098 11/2025 M2300664 11/2025 b) Lot #: Expiry Date: M2210808 06/2025 M2212212 08/2025 M2214435 09/2025 M2217097 11/2025 M2301921 01/2026
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, N Class II ongoing
Dr. Reddy's Laboratories, Inc. 2024-10-09 lots: Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202741, & T2202740, Exp 06/2025; T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, Exp 07/2025; T2300770, T2300771, T2300769, T2300766, T2300767 & T2300768, Exp 12/2025 Lots T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658 & T2301659, Exp Date 02/2026 Lots T2304704, T2304703, T2304705, T2304706, Exp Date 08/2026 Lots T2400468, T2400469, T2400473 & T2400474 Exp Date 11/2026
RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.