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Teva Pharmaceuticals USA

Teva Pharmaceuticals USA Recalls

All product recalls associated with Teva Pharmaceuticals USA.

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Recall Summary

Total Recalls

1000

Past Year

303

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 1481–1500 of 4747 recalls

Cephalexin Oral Suspension 250mg (Teva) – Medication Potency (2020)

Sub-Potent Drug: Out of specification test results for potency (below specification).

Class IIModerate

FDAAug 24, 2020Nationwide• Teva Pharmaceuticals USA

Roche Diagnostics Operations, Inc.: Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602...

Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.

FDAAug 20, 2020Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension LOCI High Sensitivity Troponin I (TNIH) Flex re...

Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed

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FDAAug 19, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Metformin Extended-Release 750mg (Bayshore) – Manufacturing Issues (2020)

CGMP Deviations

Class IIModerate

FDAAug 19, 2020Nationwide• BAYSHORE PHARMACEUTICALS

Metformin Extended-Release 500mg (Bayshore) – Manufacturing Issues (2020)

CGMP Deviations

Class IIModerate

FDAAug 19, 2020Nationwide• BAYSHORE PHARMACEUTICALS

Buprenorphine HCl Injection (Hikma) – Potency Deviation (2020)

Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

Class IIModerate

FDAAug 14, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

Pharmaceutical Innovations, Inc.: Ultra/Phonic Focus BP Conforming Gel Pads, UDI 0030036130...

The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.

FDAAug 13, 2020Nationwide• Pharmaceutical Innovations, Inc.

BusPIRone Tablets (Par Pharmaceutical) - Impurity Specs (2020)

Failed Impurity /Degradation Specifications

Class IIModerate

FDAAug 10, 2020Nationwide• Par Pharmaceutical Inc.

Nystatin Oral Suspension (PAI Holdings) – subpotent medication (2020)

Subpotent drug: Out of specification for assay at the 15-month test interval.

Class IIModerate

FDAAug 4, 2020Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Heparin Sodium 5,000 Units (SCA) – Subpotent Drug (2020)

Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

Class IIModerate

FDAJul 29, 2020Nationwide• SCA Pharmaceuticals

Heparin Sodium 2,500 Units (SCA) – Undeclared Preservatives (2020)

Undeclared Allergen

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

Class IHigh

FDAJul 29, 2020Nationwide• SCA Pharmaceuticals

Intrinsic Therapeutics, Inc.: Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Produc...

The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner container (box) is incorrect. It states BAR-A8-10MM instead of BAR-A8-8MM.

FDAJul 24, 2020Nationwide• Intrinsic Therapeutics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista High Sensitivity Troponin I (TNIH) Flex r...

Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples

FDAJul 24, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

VILAMIT MB (Vilvet) – Quality Deviation (2020)

cGMP deviations

Class IIModerate

FDAJul 24, 2020Nationwide• Vilvet Pharmaceuticals Inc.

VILEVEV MB Urinary Antispetic (Vilvet) – Quality Deviation (2020)

cGMP deviations

Class IIModerate

FDAJul 24, 2020Nationwide• Vilvet Pharmaceuticals Inc.

Barbecue All Purpose Rub (Stick E Fingers) – undeclared milk (2020)

Ingredients statement declares butter but does not declare milk or buttermilk.

Class IIModerate

FDAJul 23, 2020NY, OR, WA• Stick E Fingers BBQ LLC

Mibelas 24 Fe (Lupin) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.

Class IIModerate

FDAJul 21, 2020Nationwide• Lupin Pharmaceuticals Inc.

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Teva Pharmaceuticals USA Recalls

Recall Summary

Cephalexin Oral Suspension 250mg (Teva) – Medication Potency (2020)

Roche Diagnostics Operations, Inc.: Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602...

Siemens Healthcare Diagnostics, Inc.: Dimension LOCI High Sensitivity Troponin I (TNIH) Flex re...

Metformin Extended-Release 750mg (Bayshore) – Manufacturing Issues (2020)

Metformin Extended-Release 500mg (Bayshore) – Manufacturing Issues (2020)

Buprenorphine HCl Injection (Hikma) – Potency Deviation (2020)

Pharmaceutical Innovations, Inc.: Ultra/Phonic Focus BP Conforming Gel Pads, UDI 0030036130...

BusPIRone Tablets (Par Pharmaceutical) - Impurity Specs (2020)

Nystatin Oral Suspension (PAI Holdings) – subpotent medication (2020)

Heparin Sodium 5,000 Units (SCA) – Subpotent Drug (2020)

Heparin Sodium 2,500 Units (SCA) – Undeclared Preservatives (2020)

Heparin Sodium 10,000 Units (SCA) – Undeclared Preservatives (2020)

Heparin Sodium 5,000 Units (SCA) – Undeclared Preservatives (2020)

Heparin Sodium 5,000 Units (SCA) – Undeclared Preservatives (2020)

Intrinsic Therapeutics, Inc.: Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Produc...

Siemens Healthcare Diagnostics, Inc.: Dimension Vista High Sensitivity Troponin I (TNIH) Flex r...

VILAMIT MB (Vilvet) – Quality Deviation (2020)

VILEVEV MB Urinary Antispetic (Vilvet) – Quality Deviation (2020)

Barbecue All Purpose Rub (Stick E Fingers) – undeclared milk (2020)

Mibelas 24 Fe (Lupin) – Impurity Specification Failure (2020)