Columbus, OH, United States
American Health Packaging recalls
29 recalls recorded since 2018, most recently on 6 October 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls29
Ongoing (FDA)2
Terminated or completed27
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 6 October 2026
- Reason
- Presence of Foreign Tablets/Capsules
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0042-2027
- Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11
Ongoing Class III Drugs
- Recall started
- 19 August 2026
- Reason
- Labeling: Label Mix-up
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0840-2026
- Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).
Terminated Class III Drugs
- Recall started
- 3 May 2022
- Terminated
- 28 September 2023
- 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.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0880-2022
- Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, C
Terminated Class III Drugs
- Recall started
- 12 April 2022
- Terminated
- 28 December 2022
- Reason
- Subpotent Drug: Out of specification for assay.
- Distribution
- Alabama
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0790-2022
- Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for
Terminated Class II Drugs
- Recall started
- 22 February 2022
- Terminated
- 16 July 2023
- Reason
- Impurity failure at 0-time of the repackaged lot.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0652-2022
- 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, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Ca
Terminated Class II Drugs
- Recall started
- 20 December 2021
- Terminated
- 9 March 2023
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0451-2022
- Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03
Terminated Class II Drugs
- Recall started
- 17 September 2021
- Terminated
- 8 June 2023
- Reason
- Failed Dissolution Specifications: results were above specification.
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0020-2022
- GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Ph
Terminated Class II Drugs
- Recall started
- 15 September 2021
- Terminated
- 8 June 2023
- Reason
- CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0854-2021
- 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 Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687
Terminated Class III Drugs
- Recall started
- 12 May 2021
- Terminated
- 25 August 2022
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0813-2021
- Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
Terminated Class II Drugs
- Recall started
- 7 January 2021
- Terminated
- 3 August 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0232-2021
- Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Bl
Terminated Class III Drugs
- Recall started
- 10 June 2020
- Terminated
- 3 August 2022
- Reason
- Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1372-2020
- Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11
Terminated Class II Drugs
- Recall started
- 19 May 2020
- Terminated
- 3 August 2022
- Reason
- Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1293-2020
- Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11
Terminated Class II Drugs
- Recall started
- 7 February 2020
- Terminated
- 4 August 2022
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0848-2020, D-0849-2020
- Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-60
- Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-60
Terminated Class II Drugs
- Recall started
- 4 December 2019
- Terminated
- 4 August 2022
- Reason
- Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0854-2020
- Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-
Terminated Class II Drugs
- Recall started
- 20 November 2019
- Terminated
- 4 August 2022
- Reason
- CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1003-2020
- Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322
Terminated Class II Drugs
- Recall started
- 1 November 2019
- Terminated
- 3 August 2022
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0631-2020
- Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-
Terminated Class III Drugs
- Recall started
- 27 August 2019
- Terminated
- 9 September 2020
- 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.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1847-2019
- Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH
Terminated Class II Drugs
- Recall started
- 9 August 2019
- Terminated
- 6 November 2020
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1821-2019
- Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 680
Terminated Class II Drugs
- Recall started
- 13 May 2019
- Terminated
- 30 September 2020
- Reason
- GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1431-2019, D-1434-2019, D-1433-2019, D-1432-2019
- Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25
- Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
- Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25
- Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
Terminated Class II Drugs
- Recall started
- 9 May 2019
- Terminated
- 30 September 2020
- Reason
- GMP Deviations: Potential cross contamination due to cleaning procedure failure.
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1394-2019
- Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21.
Terminated Class II Drugs
- Recall started
- 9 May 2019
- Terminated
- 9 September 2020
- Reason
- GMP Deviations: Potential cross contamination due to cleaning procedure failure.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1467-2019
- 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 Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories
Terminated Class II Drugs
- Recall started
- 8 April 2019
- Terminated
- 6 November 2020
- Reason
- Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1276-2019
- GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
Terminated Class II Drugs
- Recall started
- 6 March 2019
- Terminated
- 9 September 2020
- Reason
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1047-2019
- Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-13
Terminated Class II Drugs
- Recall started
- 1 March 2019
- Terminated
- 30 September 2020
- Reason
- Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1820-2019
- Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-3
Terminated Class III Drugs
- Recall started
- 19 February 2019
- Terminated
- 9 September 2020
- Reason
- CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
- Distribution
- Nationwide within the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1584-2019
- 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, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
Terminated Class III Drugs
- Recall started
- 9 November 2018
- Terminated
- 30 September 2020
- 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. 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."
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0273-2019
- Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-4
Terminated Class II Drugs
- Recall started
- 1 August 2018
- Terminated
- 30 September 2020
- Reason
- Failed Dissolution Specifications: Out of specification result for the dissolution test.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1582-2019
- Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-
Terminated Class III Drugs
- Recall started
- 25 June 2018
- Terminated
- 29 April 2020
- Reason
- Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
- Distribution
- Lot#166023 products distributed from 12/29/16 to 1/19/17 and Lot#168467 distributed from 4/6/17 to 9/11/17. Distributors are the wholesalers who received the product; others are the Corporate Offices for those wholesalers.
- Recall number
- D-0915-2018
- Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit D
Terminated Class II Drugs
- Recall started
- 19 January 2018
- Terminated
- 14 March 2019
- Reason
- CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0595-2018
- Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.