American Health Packaging Recalls

All product recalls associated with American Health Packaging.

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Recall Summary

Total Recalls

59

Past Year

0

Class I (Serious)

2

Most Recent

May 2022

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 1–20 of 59 recalls

Nitrofurantoin Capsules (American Health) – Dissolution Failure (2022)

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

Class IIILow

FDAMay 3, 2022Nationwide• American Health Packaging

Cyanocobalamin Injection (American Health) – Subpotent Drug (2022)

Subpotent Drug: Out of specification for assay.

Class IIILow

FDAApr 12, 2022AL• American Health Packaging

Oxycodone Hydrochloride Oral Solution (American Health) – Impurity Failure (2022)

Impurity failure at 0-time of the repackaged lot.

Class II

Moderate

FDAFeb 22, 2022Nationwide• American Health Packaging

Metoprolol Succinate Tablets (American Health) – Dissolution Failure (2021)

Failed Dissolution Specifications

Class IIModerate

FDADec 20, 2021Nationwide• American Health Packaging

GlipiZIDE Tablets (American Health) – Dissolution Failed (2021)

Failed Dissolution Specifications: results were above specification.

Class IIModerate

FDASep 17, 2021Nationwide• American Health Packaging

Valproic Acid Oral Solution (American Health) – Microbial Contamination (2021)

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

Class IIModerate

FDASep 15, 2021Nationwide• American Health Packaging

Sirolimus Tablets 1 mg (American Health) – Impurity Specs (2021)

Failed Impurities/Degradation Specifications

Class IIILow

FDAMay 12, 2021Nationwide• American Health Packaging

Nitrofurantoin Capsules (American Health) – Dissolution Failure (2021)

Failed Dissolution Specifications

Class IIModerate

FDAJan 7, 2021Nationwide• American Health Packaging

Nabumetone Tablets (American Health Packaging) – Incomplete Labeling (2020)

Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.

Class IIILow

FDAJun 10, 2020Nationwide• American Health Packaging

Doxycycline Tablets (American Health) – Failed Dissolution (2020)

Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).

Class IIModerate

FDAMay 19, 2020Nationwide• American Health Packaging

Desmopressin Tablets (American Health) – Missing Desiccant (2020)

GMP Deviations: Product bottle may be absent of desiccant.

Class IIModerate

FDAFeb 7, 2020Nationwide• American Health Packaging

Desmopressin Tablets (American Health) – Missing Desiccant (2020)

GMP Deviations: Product bottle may be absent of desiccant.

Class IIModerate

FDAFeb 7, 2020Nationwide• American Health Packaging

Raloxifene Tablets (American Health) – Failed Dissolution (2019)

Failed Dissolution Specifications: Low out of specification results obtained during stability testing.

Class IIModerate

FDADec 4, 2019Nationwide• American Health Packaging

Ranitidine Tablets 150mg (American Health) – NDMA Concern (2019)

CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Class IIModerate

FDANov 20, 2019Nationwide• American Health Packaging

Ranitidine Syrup (American Health) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDANov 1, 2019Nationwide• American Health Packaging

Lamivudine Tablets (American Health) – Labeling Error (2019)

Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.

Class IIILow

FDAAug 27, 2019Nationwide• American Health Packaging