Cipla USA Recalls
An assortment of pharmaceutical pills (representative file photo). Specific recalled product: see recall details below. Photo: Michael Nutt / Wikimedia Commons (CC BY-SA 2.0).
- Recalls in database
- 17
- Agency
- FDA
- Years covered
- 2025–2026
How this hub is built. This page collects 8 recall events tied to Cipla USA (across 17 product-line records) in the current 411 Press recall dataset. A note on counting. The three agencies package recalls differently. NHTSA issues one record per safety campaign; the CPSC issues one per recall; the FDA issues one per affected product line, so a single FDA recall can appear as dozens of records. Counting raw records would push FDA-heavy brands artificially to the top. The counts here are recall EVENTS — distinct agency events — with the FDA product-line record total shown alongside wherever the two differ. Records are grouped by a normalized version of the recalling firm's name (normalizer version 2026-07-28.C3.2). Parent, subsidiary, and "doing business as" relationships are not merged unless the agency data states them, so a corporate family can appear under more than one name. Regulator for these records: FDA. They were published 2025–2026. An event count reflects how much recall activity fell inside the current dataset — not a ranking of relative safety. Larger manufacturers and higher-volume product lines generate more recall activity. This is the current dataset, not an all-time total, and it grows as new notices are ingested. Every row links to the original agency notice.
2026 (11)
- Class II
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- Class II
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- Class II
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- Class II
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- Class II
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- Class II
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- Class II
Lanreotide Injection
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- Class II
Lanreotide Injection
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- Class III
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Class III
Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Class II
Lanreotide Injection
Presence of Particulate Matter.
2025 (6)
- Class III
Diclofenac Sodium Topical Gel
Failed PH Specifications
- Class II
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Class II
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Class II
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Class II
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
- Class II
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test