Jubilant Cadista Pharmaceuticals, Inc.
Complete recall history across all FDA and CPSC categories — 29 total recalls
Jubilant Cadista Pharmaceuticals, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (29)
FDA drug safety enforcement actions by Jubilant Cadista Pharmaceuticals, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 27, 2022 | Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cad... | Subpotent Drug: Out of specification for assay at the 18-month stability time... | Class III |
| Jul 18, 2022 | Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: ... | Failed dissolution specifications. | Class II |
| Jul 18, 2022 | Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: J... | Failed Dissolution Specifications | Class II |
| Apr 1, 2022 | Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured ... | Subpotent | Class III |
| Mar 8, 2022 | Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottle... | Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labe... | Class I |
| Aug 20, 2021 | Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: ... | Subpotent | Class III |
| Apr 1, 2021 | Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Ju... | Failed Dissolution Specifications | Class II |
| Feb 19, 2021 | Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx... | Labeling: Illegible label: Customer complaint received of mis-alignment print... | Class III |
| Nov 6, 2020 | clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Man... | Failed Tablet/Capsule Specification | Class II |
| Oct 26, 2020 | Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) bli... | Subpotent | Class III |
| May 26, 2020 | Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured b... | Presence of Foreign Substance visually consistent with the silica granules pr... | Class III |
| Mar 11, 2020 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx ... | CGMP Deviations: Presence of dark brown discoloration on edges of tablets | Class II |
| Dec 2, 2019 | Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufact... | Presence of Foreign Substance: Presence of a foreign object in a single tablet. | Class II |
| Sep 4, 2019 | Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count... | CGMP Deviation: Presence of dark brown discoloration on edges of tablets. | Class II |
| Jul 9, 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... | Failed dissolution specifications : failed results at the 3-month stability t... | Class I |
| Mar 29, 2019 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... | Discoloration: Expansion of an earlier recall due to the presence of dark bro... | Class II |
| Feb 28, 2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 coun... | Failed Dissolution Specifications; 9-monthstability timepoint | Class III |
| Oct 2, 2018 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... | Discoloration: Presence of dark discoloration or brown spots on the edges of ... | Class II |
| Aug 27, 2018 | MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubil... | Failed Stability Specifications: An out-of-specification result was obtained ... | Class III |
| Aug 14, 2018 | Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jub... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of ex... | Class III |
| Aug 14, 2018 | Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubi... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of ex... | Class III |
| Aug 14, 2018 | Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubi... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of ex... | Class III |
| Aug 14, 2018 | Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jub... | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of ex... | Class III |
| May 25, 2018 | Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant ... | Incorrect/Undeclared excipient: Product batches were released into commercial... | Class III |
| Oct 30, 2017 | Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only,... | Marketed without an approved NDA/ANDA: Bottles were released prior to final a... | Class III |
| Jun 13, 2016 | Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactur... | Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date... | Class III |
| Apr 8, 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged ... | Failed Impurities/Degradation Specifications: high out of specification resul... | Class III |
| Apr 8, 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged ... | Failed Impurities/Degradation Specifications: high out of specification resul... | Class III |
| Apr 8, 2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged ... | Failed Impurities/Degradation Specifications: high out of specification resul... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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