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BioDiagnostic International

BioDiagnostic International Recalls

All product recalls associated with BioDiagnostic International.

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Recall Summary

Total Recalls

970

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 501–520 of 970 recalls

Monsel's Solution (BioDiagnostic) – Manufacturing Deviation (2018)

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Class IIModerate

FDAJun 11, 2018Nationwide• BioDiagnostic International

Bulk Kratom (Eden's Ethnos) – salmonella contamination (2018)

Salmonella

FDA and state samples found Salmonella in Kratom products that traced back to Eden Ethnos LLC.

Class IHigh

FDAApr 20, 2018CA, FL, MO +2 more• Eden's Ethnos, LLC

E-Z-Paste Barium Cream (Bracco) – Preservative Assay (2018)

Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.

1...24 252627 28...49

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Class IIModerate

FDAMar 8, 2018Nationwide• Bracco Diagnostics Inc.

Calcium Acetate Capsules (Nostrum Laboratories) – Foreign Tablet Contamination (2018)

Presence of Foreign Tablets/Capsules

Class IIILow

FDAFeb 13, 2018Nationwide• Nostrum Laboratories Inc

Alcohol Prep Pads (Simple Diagnostics) – Sterility Concern (2017)

Lack of Assurance of Sterility and cGMP Deviations

Class IIModerate

FDASep 5, 2017Nationwide• Simple Diagnostics, Inc.

Nitrofurantoin Oral Suspension (Nostrum) – Failed Dissolution Test (2016)

Failed Dissolution Specifications

Class IIModerate

FDAMay 23, 2016Nationwide• Nostrum Laboratories, Inc.

Canned Seafood (Ballester Hermanos) – Mislabeled Product (2016)

Product label states name and ingredients as Octopus and real content is Squid.

Class IIModerate

FDAMay 12, 2016PR• Ballester Hermanos, Inc.

Canned Seafood (Ballester Hermanos) – Mislabeled Product (2016)

Product label states name and ingredients as Octopus and real content is Squid.

Class IIModerate

FDAMay 12, 2016PR• Ballester Hermanos, Inc.

Canned Seafood (Ballester Hermanos) – Mislabeled Product (2016)

Product label states name and ingredients as Octopus and real content is Squid.

Class IIModerate

FDAMay 12, 2016PR• Ballester Hermanos, Inc.

Canned Seafood (Ballester Hermanos) – Mislabeled Product (2016)

Product label states name and ingredients as Octopus and real content is Squid.

Class IIModerate

FDAMay 12, 2016PR• Ballester Hermanos, Inc.