Manufacturer profile
Cariba International
Pharmaceutical company3 products tracked
3
products tracked
113,143
total reports
189
recalls on record
92.6%
serious overall
Products
showing 3 of 3
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1946 | 46,199 | Helicobacter infection | 100 | |
| — | 33,499 | Duodenal ulcer perforation | 18 | |
| 2000 | 33,445 | Duodenal ulcer perforation | 71 |
Recall history · 50 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Apr 22, 2026 | II | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC |
| Apr 22, 2026 | II | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC |
| Mar 2, 2026 | I | Non-Sterility: microbial contamination identified as Paenibacillus phoenicis | Cardinal Health 200, LLC |
| Jan 20, 2026 | II | CGMP Deviations | ACME UNITED CORPORATION |
| Jan 20, 2026 | II | CGMP Deviations | ACME UNITED CORPORATION |
| Dec 26, 2025 | II | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC |
| Sep 29, 2025 | II | Subpotent Drug | Medline Industries, LP |
| Sep 29, 2025 | II | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. | Acuity Specialty Products, Inc. |
| Aug 25, 2025 | III | Cross Contamination with Other Products. | Consumer Product Partners, LLC |
| Aug 25, 2025 | III | Cross Contamination with Other Products. | Consumer Product Partners, LLC |
| Jul 7, 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 7, 2025 | II | Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol | Consumer Product Partners, LLC |
| Feb 17, 2025 | II | Subpotent Drug | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 12, 2025 | II | Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. | Wuxi Medical lnstrument Factory Co., Ltd. |
| Sep 18, 2024 | II | CGMP deviations | EnviroServe Chemicals Inc. |
| Aug 8, 2024 | II | Superpotent Drug | Teva Pharmaceuticals USA, Inc |
| Aug 5, 2024 | II | CGMP Deviations: sterile water not used for production | Zeco LLC |
| Aug 5, 2024 | II | CGMP Deviations: sterile water not used for production | Zeco LLC |
| Mar 23, 2024 | I | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. |
| Nov 13, 2023 | I | Non-Sterility | Kilitch Healthcare India Limited |
| Oct 31, 2023 | I | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. |
| Oct 18, 2023 | II | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts. | Integrity Bio-Chemicals LLC |
| Aug 25, 2023 | II | Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides. | CareFusion 213, LLC |
| Apr 26, 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| Apr 20, 2023 | I | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Novis PR, LLC dba Kramer Novis |
| Mar 27, 2023 | II | CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products. | Jarman's Midwest Cleaning Systems, Inc. |
| Feb 23, 2023 | II | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation |
| Feb 14, 2023 | I | Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits. | Nanomaterials Discovery Corporation |
| Jan 17, 2023 | II | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022. | Fisher Scientific Co., LLC |
| Jan 17, 2023 | II | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022. | Fisher Scientific Co., LLC |
| Jan 17, 2023 | II | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Urban Electric Power |
| Dec 15, 2022 | II | cGMP Deviations | Frenda Corporation |
| Dec 15, 2022 | II | cGMP Deviations | Frenda Corporation |
| Dec 15, 2022 | II | cGMP Deviations | Frenda Corporation |
| Dec 15, 2022 | II | cGMP Deviations | Frenda Corporation |
| Dec 9, 2022 | II | CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits. | NCH Life Sciences LLC |
| Nov 5, 2022 | I | Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol. | Adam's Polishes LLC |
| Nov 5, 2022 | II | CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Adam's Polishes LLC |
| Oct 6, 2022 | II | CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent. | Southwest Iowa Renewable Energy LLC |
| Sep 14, 2022 | I | Chemical Contamination: product found to contain benzene | Salon Technologies International Inc |
| Aug 15, 2022 | II | Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process. | Ultra Chem Labs Corp |
| Jul 19, 2022 | II | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC |
| Jul 19, 2022 | II | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC |
| Jun 23, 2022 | II | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. |
| Jun 15, 2022 | II | Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening. | Vi-Jon, LLC |
| Apr 5, 2022 | II | CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. | Lula Holdings L.L.C. |
| Mar 3, 2022 | I | Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol. | Tennessee Technical Coatings, Corp. |
| Mar 3, 2022 | II | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Tennessee Technical Coatings, Corp. |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Cariba International are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.