American Health Packaging recalls
FDA enforcement reports naming American Health Packaging as the recalling firm.
- Recall reports
- 60
- Class I (serious)
- 2
- Most recent report
- Sep 9, 2026
- Sep 9, 2026Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed…Drug · American Health PackagingLabeling: Label Mix-upClass III
- May 25, 2022Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10…Drug · American Health PackagingFailed 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 III
- May 4, 2022Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use O…Drug · American Health PackagingSubpotent Drug: Out of specification for assay.Class III
- Mar 16, 2022Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1…Drug · American Health PackagingImpurity failure at 0-time of the repackaged lot.Class II
- Feb 2, 2022Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Ma…Drug · American Health PackagingFailed Dissolution SpecificationsClass II
- Oct 27, 2021GlipiZIDE Extended-Release Tablets, 2Drug · American Health PackagingFailed Dissolution Specifications: results were above specification.Class II
- Oct 6, 2021Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx O…Drug · American Health PackagingCGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.Class II
- Sep 29, 2021Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged…Drug · American Health PackagingFailed Impurities/Degradation SpecificationsClass III
- Jan 27, 2021Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 cap…Drug · American Health PackagingFailed Dissolution SpecificationsClass II
- Jul 1, 2020Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards)…Drug · American Health PackagingLabeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.Class III
- Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Dist…
- Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, P…
- Desmopressin Acetate Tablets, 0
- Desmopressin Acetate Tablets, 0
- Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Onl…
- Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Onl…
- Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton
- Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10…
- Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carto…
- Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and…
- Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blist…
- Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 6800…
- Pramipexole Dihydrochloride Tablets, 0
- Pramipexole Dihydrochloride Tablets, 0
- Pramipexole Dihydrochloride Tablets, 0
- Pramipexole Dihydrochloride Tablets, 1
- Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Package…
- GlipiZIDE Extended-release Tablets, 2
- Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, P…
- Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Bl…
- Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a…
- Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-17…
- Desmopressin Acetate Tablets, 0
- Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11)
- Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11)
- Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11)
- Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11)
- Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11)
- Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11)
- Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11)
- Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11)
- Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11)
- Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11)
- Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11)
- Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11)
- Amlodipine besylate tablets, USP 2
- Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packa…
- Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed…
- Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton,…
- MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed…
- Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and…
- Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and…
- HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC
- HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC
- Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged…
- buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blis…
- Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 car…
- QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Di…
- Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton,…
- Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mf…
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