American Health Packaging recalls
American Health Packaging appears in 61 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 61 |
|---|---|
| Published | 2012-08-22 to 2026-10-21 |
| By agency | FDA Drug (61) |
| By classification | Class II (46), Class III (13), Class I (2) |
| By status | terminated (59), ongoing (2) |
| Distribution named in notices | AL, US |
Recalls
- Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217
FDA Drug · Class II · 2026-10-21 · American Health Packaging
Reason: Presence of Foreign Tablets/Capsules - Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217…
FDA Drug · Class III · 2026-09-09 · American Health Packaging
Reason: Labeling: Label Mix-up - Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton,…
FDA Drug · Class III · 2022-05-25 · American Health Packaging
Reason: 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. - Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugi…
FDA Drug · Class III · 2022-05-04 · American Health Packaging
Reason: Subpotent Drug: Out of specification for assay. - Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only…
FDA Drug · Class II · 2022-03-16 · American Health Packaging
Reason: Impurity failure at 0-time of the repackaged lot. - Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400…
FDA Drug · Class II · 2022-02-02 · American Health Packaging
Reason: Failed Dissolution Specifications - GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured b…
FDA Drug · Class II · 2021-10-27 · American Health Packaging
Reason: Failed Dissolution Specifications: results were above specification. - Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Pa…
FDA Drug · Class II · 2021-10-06 · American Health Packaging
Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. - Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columb…
FDA Drug · Class III · 2021-09-29 · American Health Packaging
Reason: Failed Impurities/Degradation Specifications - Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by:…
FDA Drug · Class II · 2021-01-27 · American Health Packaging
Reason: Failed Dissolution Specifications - Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging…
FDA Drug · Class III · 2020-07-01 · American Health Packaging
Reason: Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. - Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohi…
FDA Drug · Class II · 2020-06-17 · American Health Packaging
Reason: Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life). - Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packagin…
FDA Drug · Class II · 2020-03-18 · American Health Packaging
Reason: CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. - Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Pa…
FDA Drug · Class II · 2020-02-26 · American Health Packaging
Reason: GMP Deviations: Product bottle may be absent of desiccant. - Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Pa…
FDA Drug · Class II · 2020-02-26 · American Health Packaging
Reason: GMP Deviations: Product bottle may be absent of desiccant. - Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Pack…
FDA Drug · Class II · 2020-02-19 · American Health Packaging
Reason: Failed Dissolution Specifications: Low out of specification results obtained during stability testing. - Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columb…
FDA Drug · Class II · 2020-01-08 · American Health Packaging
Reason: CGMP Deviations: Presence of NDMA impurity detected in product. - Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distribut…
FDA Drug · Class III · 2019-09-18 · American Health Packaging
Reason: 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. - Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Healt…
FDA Drug · Class II · 2019-08-21 · American Health Packaging
Reason: Failed Dissolution Specifications - Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distrib…
FDA Drug · Class II · 2019-08-21 · American Health Packaging
Reason: Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples. - Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Ma…
FDA Drug · Class III · 2019-08-14 · American Health Packaging
Reason: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. - Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packa…
FDA Drug · Class II · 2019-08-07 · American Health Packaging
Reason: Failed Dissolution Specifications: Out of specification result for the dissolution test. - Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila…
FDA Drug · Class II · 2019-07-17 · American Health Packaging
Reason: GMP Deviations: Potential cross contamination due to cleaning procedure failure. - Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, C…
FDA Drug · Class II · 2019-07-03 · American Health Packaging
Reason: GMP Deviations; possible cross contamination of product due to cleaning procedure failure. - Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Colum…
FDA Drug · Class II · 2019-07-03 · American Health Packaging
Reason: GMP Deviations; possible cross contamination of product due to cleaning procedure failure. - Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging,…
FDA Drug · Class II · 2019-07-03 · American Health Packaging
Reason: GMP Deviations; possible cross contamination of product due to cleaning procedure failure. - Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, C…
FDA Drug · Class II · 2019-07-03 · American Health Packaging
Reason: GMP Deviations; possible cross contamination of product due to cleaning procedure failure. - Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Col…
FDA Drug · Class II · 2019-06-26 · American Health Packaging
Reason: GMP Deviations: Potential cross contamination due to cleaning procedure failure. - GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus,…
FDA Drug · Class II · 2019-05-08 · American Health Packaging
Reason: Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero. - Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging…
FDA Drug · Class II · 2019-03-27 · American Health Packaging
Reason: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. - Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA Ame…
FDA Drug · Class III · 2018-11-28 · American Health Packaging
Reason: 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. San… - Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American…
FDA Drug · Class III · 2018-07-18 · American Health Packaging
Reason: Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant - Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11
FDA Drug · Class II · 2018-02-21 · American Health Packaging
Reason: CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. - Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons
FDA Drug · Class III · 2015-07-22 · American Health Packaging
Reason: Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. - Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11)
FDA Drug · Class II · 2015-07-15 · American Health Packaging
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, C…
FDA Drug · Class II · 2015-06-24 · American Health Packaging
Reason: Failed dissolution specifications - Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217…
FDA Drug · Class II · 2015-04-08 · American Health Packaging
Reason: Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules - Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc…
FDA Drug · Class II · 2014-12-24 · American Health Packaging
Reason: 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.