American Health Packaging
Complete recall history across all FDA and CPSC categories — 59 total recalls
American Health Packaging appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (59)
FDA drug safety enforcement actions by American Health Packaging. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 3, 2022 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsule... | Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to di... | Class III |
| Apr 12, 2022 | Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutan... | Subpotent Drug: Out of specification for assay. | Class III |
| Feb 22, 2022 | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL p... | Impurity failure at 0-time of the repackaged lot. | Class II |
| Dec 20, 2021 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, R... | Failed Dissolution Specifications | Class II |
| Sep 17, 2021 | GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each ... | Failed Dissolution Specifications: results were above specification. | Class II |
| Sep 15, 2021 | Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per ... | CGMP Deviations: Potential concern with products manufactured using liquid su... | Class II |
| May 12, 2021 | Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only,... | Failed Impurities/Degradation Specifications | Class III |
| Jan 7, 2021 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per cart... | Failed Dissolution Specifications | Class II |
| Jun 10, 2020 | Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blis... | Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with t... | Class III |
| May 19, 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx ... | Failed dissolution specification - dissolution results of 59% (spec. NLT 85%)... | Class II |
| Feb 7, 2020 | Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister ca... | GMP Deviations: Product bottle may be absent of desiccant. | Class II |
| Feb 7, 2020 | Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister ca... | GMP Deviations: Product bottle may be absent of desiccant. | Class II |
| Dec 4, 2019 | Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... | Failed Dissolution Specifications: Low out of specification results obtained ... | Class II |
| Nov 20, 2019 | Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), ... | CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels... | Class II |
| Nov 1, 2019 | Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per c... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II |
| Aug 27, 2019 | Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, N... | Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms ... | Class III |
| Aug 9, 2019 | Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister c... | Failed Dissolution Specifications | Class II |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only,... | GMP Deviations; possible cross contamination of product due to cleaning proce... | Class II |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per bliste... | GMP Deviations; possible cross contamination of product due to cleaning proce... | Class II |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per bliste... | GMP Deviations; possible cross contamination of product due to cleaning proce... | Class II |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blis... | GMP Deviations; possible cross contamination of product due to cleaning proce... | Class II |
| May 9, 2019 | Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Onl... | GMP Deviations: Potential cross contamination due to cleaning procedure failure. | Class II |
| May 9, 2019 | Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count... | GMP Deviations: Potential cross contamination due to cleaning procedure failure. | Class II |
| Apr 8, 2019 | GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Pac... | Failed Dissolution Specifications: dissolution failure at time zero of the re... | Class II |
| Mar 6, 2019 | Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, ... | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impur... | Class II |
| Mar 1, 2019 | Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules... | Failed Impurities/Degradation Specifications; out of specification result for... | Class II |
| Feb 19, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-31... | CGMP Deviations: Finished product made with lovastatin drug substance that wa... | Class III |
| Nov 9, 2018 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Un... | Cross contamination with other products: This sub-recall is being initiated i... | Class III |
| Aug 1, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit ... | Failed Dissolution Specifications: Out of specification result for the dissol... | Class II |
| Jun 25, 2018 | Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 ca... | Failed Impurities/Degradation Specification; out-of-specification results for... | Class III |
| Jan 19, 2018 | Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [N... | CGMP Deviations: lot made with active pharmaceutical ingredient that did not ... | Class II |
| Jun 26, 2015 | Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3... | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted ... | Class III |
| Jun 1, 2015 | Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11)... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 6808... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11)... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11)... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11);... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-1... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Jun 1, 2015 | Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-4... | CGMP Deviations: Firm did not adequately investigate customer complaints. | Class II |
| Mar 2, 2015 | Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx O... | Failed dissolution specifications | Class II |
| Jan 6, 2015 | Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and D... | Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to... | Class II |
| Nov 19, 2014 | Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe... | Failed USP Dissolution Test Requirements: This sub-recall is in response to P... | Class II |
| Oct 10, 2014 | MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and D... | Subpotent; 6 month stability time point | Class III |
| Jul 1, 2014 | Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lo... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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