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American Health Packaging Recalls
59 recalls on record · August 22, 2012 to May 25, 2022 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 25, 2022DrugsFDA
American Health Packaging recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10
Hazard: 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.
May 4, 2022DrugsFDA
American Health Packaging recalls Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Ma
Hazard: Subpotent Drug: Out of specification for assay.
March 16, 2022DrugsFDA
American Health Packaging recalls Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Ins
Hazard: Impurity failure at 0-time of the repackaged lot.
February 2, 2022DrugsFDA
American Health Packaging recalls Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories
Hazard: Failed Dissolution Specifications
October 27, 2021DrugsFDA
American Health Packaging recalls GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx o
Hazard: Failed Dissolution Specifications: results were above specification.
October 6, 2021DrugsFDA
American Health Packaging recalls Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by:
Hazard: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
September 29, 2021DrugsFDA
American Health Packaging recalls Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Heal
Hazard: Failed Impurities/Degradation Specifications
January 27, 2021DrugsFDA
American Health Packaging recalls Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx onl
Hazard: Failed Dissolution Specifications
July 1, 2020DrugsFDA
American Health Packaging recalls Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: Americ
Hazard: Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
June 17, 2020DrugsFDA
American Health Packaging recalls Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packa
Hazard: Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
March 18, 2020DrugsFDA
American Health Packaging recalls Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: Ameri
Hazard: CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
February 26, 2020DrugsFDA
American Health Packaging recalls Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by:
Hazard: GMP Deviations: Product bottle may be absent of desiccant.
February 26, 2020DrugsFDA
American Health Packaging recalls Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by:
Hazard: GMP Deviations: Product bottle may be absent of desiccant.
February 19, 2020DrugsFDA
American Health Packaging recalls Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: A
Hazard: Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
January 8, 2020DrugsFDA
American Health Packaging recalls Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Healt
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
September 18, 2019DrugsFDA
American Health Packaging recalls Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687
Hazard: 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.
August 21, 2019DrugsFDA
American Health Packaging recalls Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed
Hazard: Failed Dissolution Specifications
August 21, 2019DrugsFDA
American Health Packaging recalls Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses
Hazard: Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
August 14, 2019DrugsFDA
American Health Packaging recalls Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-3
Hazard: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
August 7, 2019DrugsFDA
American Health Packaging recalls Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: A
Hazard: Failed Dissolution Specifications: Out of specification result for the dissolution test.
July 17, 2019DrugsFDA
American Health Packaging recalls Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manuf
Hazard: GMP Deviations: Potential cross contamination due to cleaning procedure failure.
July 3, 2019DrugsFDA
American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American
Hazard: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
July 3, 2019DrugsFDA
American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American
Hazard: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
July 3, 2019DrugsFDA
American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Hea
Hazard: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
July 3, 2019DrugsFDA
American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: Americ
Hazard: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
June 26, 2019DrugsFDA
American Health Packaging recalls Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American H
Hazard: GMP Deviations: Potential cross contamination due to cleaning procedure failure.
May 8, 2019DrugsFDA
American Health Packaging recalls GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health
Hazard: Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
March 27, 2019DrugsFDA
American Health Packaging recalls Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: Amer
Hazard: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
November 28, 2018DrugsFDA
AMERICAN HEALTH PACKAGING recalls Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Heal
Hazard: Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
July 18, 2018DrugsFDA
AMERICAN HEALTH PACKAGING recalls Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distri
Hazard: Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant