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American Pharmaceutical Ingredients LLC

American Pharmaceutical Ingredients LLC Recalls

All product recalls associated with American Pharmaceutical Ingredients LLC.

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

34

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 2501–2520 of 4747 recalls

Baclofen USP Micronized (American Pharmaceutical) – Stability Data Deficiency (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Duloxetine HCl USP (American Pharmaceutical) – Stability Data Deficiency (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Oxandrolone USP (American Pharmaceutical) – Stability Data Deficiency (2018)

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CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Phentolamine Mesylate USP (American Pharmaceutical) – Stability Data Deficiency (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Prilocaine HCl USP (American Pharmaceutical) – Expiration Date Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Clonidine HCl USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Tacrolimus USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Diclofenac Sodium USP (American Pharmaceutical) – Stability Data Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Gabapentin USP (American Pharmaceutical) – Stability Data Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Levothyroxine Sodium USP (American Pharmaceutical) – Stability Data Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Medroxyprogesterone Acetate USP (American Pharmaceutical) – Stability Data Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Sumatriptan USP (American Pharmaceutical) – quality control issue (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Vardenafil HCl USP (American Pharmaceutical) – quality control issue (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Clindamycin Phosphate USP (American Pharmaceutical) – quality control issue (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Lincomycin HCl USP (American Pharmaceutical) – quality control issue (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Levofloxacin Hemihydrate USP (American Pharmaceutical) – quality control issue (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Lidocaine USP (American Pharmaceutical) – quality control issue (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Cyclosporine USP (American Pharmaceutical Ingredients) – Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Celecoxib USP (American Pharmaceutical Ingredients) – Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Estriol USP (American Pharmaceutical Ingredients) – Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC