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SCA Pharmaceuticals, LLC

SCA Pharmaceuticals, LLC Recalls

All product recalls associated with SCA Pharmaceuticals, LLC.

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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 1801–1820 of 4747 recalls

Lidocaine HCl Injection (SCA Pharma) – Foreign Material (2019)

Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).

Class IIModerate

FDANov 26, 2019Nationwide• SCA Pharmaceuticals, LLC

VCF Vaginal Contraceptive Foam (Apothecus) – Propellant Leakage (2019)

Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable

Class IIILow

FDANov 25, 2019Nationwide• Apothecus Pharmaceutical Corp.

Ranitidine Syrup (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class II

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Moderate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 300mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 300mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 150mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 150mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ibuprofen Oral Suspension (Preferred) – Foreign Particles (2019)

Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Class IIModerate

FDANov 21, 2019CA, FL, IL• Preferred Pharmaceuticals, Inc

EXPAREL Bupivacaine Suspension (Pacira) – Potency Issue (2019)

Sub Potent Drug: Out of Specification (OOS)

Class IIModerate

FDANov 21, 2019Nationwide• Pacira Pharmaceuticals, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry CardioPhase High Sensitivity C-Reactive P...

Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.

FDANov 19, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH High Sensitivity C-Reactive Protein (HsCRP) C...

Atellica CH: The Atellica CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica CH Analyzer.

FDANov 19, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Diagnostica Stago, Inc.: STA UNICALIBRATOR (ref. 00675)

A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

FDANov 18, 2019AL, AK, AZ +39 more• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: STA SYSTEM CONROL N + P (ref. 00678)

FDANov 18, 2019AL, AK, AZ +39 more• Diagnostica Stago, Inc.

Timolol Maleate Ophthalmic Solution (Rising) – Labeling Mix-up (2019)

Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.

Class IIILow

FDANov 15, 2019Nationwide• Rising Pharmaceuticals, Inc.

Timolol Maleate Ophthalmic Solution (Rising) – Labeling Error (2019)

Class IIILow

FDANov 15, 2019Nationwide• Rising Pharmaceuticals, Inc.

Clobetasol Propionate Foam (Glenmark) – Delivery System Failure (2019)

Defective delivery system; product is not foaming or is coming out as liquid.

Class IIILow

FDANov 15, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Clobetasol Propionate Foam (Glenmark) – Defective Delivery System (2019)

Defective delivery system; product is not foaming or is coming out as liquid.

Class IIILow

FDANov 15, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Hardy Diagnostics: HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and d...

False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

FDANov 14, 2019AZ, CA, IN +11 more• Hardy Diagnostics

Valganciclovir Oral Solution (Teva) – Foreign Particles (2019)

Presence of foreign substance: Brown/black particles found during stability testing.

Class IIModerate

FDANov 4, 2019Nationwide• Teva Pharmaceuticals USA, Inc.

Cefdinir Oral Suspension 125mg (Lupin) – Dead Ant Found (2019)

Presence of Foreign substance: identified as a dead ant.

Class IIILow

FDANov 1, 2019Nationwide• Lupin Pharmaceuticals Inc.