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American Health Packaging

American Health Packaging Recalls

All product recalls associated with American Health Packaging.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

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 41–59 of 59 recalls

Amlodipine Besylate 5mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Lisinopril 10mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Lisinopril 40mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class II

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Moderate

FDAJun 1, 2015Nationwide• American Health Packaging

Amlodipine Besylate 2.5mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Famotidine 20mg Tablets (American Health) - CGMP investigation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAJun 1, 2015Nationwide• American Health Packaging

Lamivudine Zidovudine Tablets (American Health) – Dissolution Failure (2015)

Failed dissolution specifications

Class IIModerate

FDAMar 2, 2015Nationwide• American Health Packaging

Benzonatate Capsules (American Health) – Wet Capsules (2015)

Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules

Class IIModerate

FDAJan 6, 2015Nationwide• American Health Packaging

Mercaptopurine Tablets (American Health) – Dissolution Failure (2014)

Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.

Class IIModerate

FDANov 19, 2014Nationwide• American Health Packaging

MethylPREDNISolone Tablets (American Health) – subpotent (2014)

Subpotent; 6 month stability time point

Class IIILow

FDAOct 10, 2014Nationwide• American Health Packaging

Oxcarbazepine Tablets 300mg (American Health) – Labeling Mix-Up (2014)

Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.

Class IHigh

FDAJul 1, 2014Nationwide• American Health Packaging

Ibuprofen Tablets 600mg (American Health) – Labeling Mix-Up (2014)

Class IHigh

FDAJul 1, 2014Nationwide• American Health Packaging

HydrOXYzine Tablets (American Health) – Unapproved Ingredient (2014)

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Class IIModerate

FDAJan 31, 2014Nationwide• American Health Packaging

HydrOXYzine Tablets (American Health) – Unapproved Ingredient (2014)

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Class IIModerate

FDAJan 31, 2014Nationwide• American Health Packaging

Valacyclovir HCl Tablets (American Health) – Potency Issue (2013)

Subpotent

Class IIModerate

FDAAug 2, 2013Nationwide• American Health Packaging

Zolpidem Tartrate Tablets (American Health) – mispackaging risk (2013)

Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.

Class IIModerate

FDAMay 21, 2013Nationwide• American Health Packaging

Bupropion Extended Release Tablets (American Health) – Stability Issue (2013)

Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

Class IIILow

FDAFeb 4, 2013Nationwide• American Health Packaging

Quetiapine Fumarate Tablets (American Health) – Dissolution Failure (2012)

Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

Class IIModerate

FDAOct 10, 2012Nationwide• American Health Packaging

Topiramate Tablets 50mg (American Health Packaging) – label error (2012)

Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".

Class IIILow

FDAJul 25, 2012Nationwide• American Health Packaging

Mercaptopurine Tablets (American Health Packaging) – dissolution failure (2012)

Class IIModerate

FDAJul 23, 2012Nationwide• American Health Packaging