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American Health Packaging
American Health Packaging: 59 FDA recall reports
Every drug recall the FDA has published for American Health Packaging. The fault, and how the agency graded it.
59Reports
2Class I
0Ongoing
2022-05-25Most recent
2 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters pe
D-0880-2022 · Class III · reported 2022-05-25 · Terminated
- Why it was recalled
- 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.
- Product
- 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, Columbus, Ohio 43217, NDC: 68084-446-01
- Where it went
- Nationwide USA
- How much
- 1603 cartons
Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, R
D-0790-2022 · Class III · reported 2022-05-04 · Terminated
- Why it was recalled
- Subpotent Drug: Out of specification for assay.
- Product
- 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 Carton: 68001-509-60; NDC for vial: 68001-509-59
- Where it went
- Alabama
- How much
- 97,975 vials
Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Onl
D-0652-2022 · Class II · reported 2022-03-16 · Terminated
- Why it was recalled
- Impurity failure at 0-time of the repackaged lot.
- Product
- 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; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40
- Where it went
- Nationwide in the USA
- How much
- 89,880 unit-dose cups
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem La
D-0451-2022 · Class II · reported 2022-02-02 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- 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
- Where it went
- Nationwide in the USA
- How much
- 6,637 500-count bottles
GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered do
D-0020-2022 · Class II · reported 2021-10-27 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: results were above specification.
- Product
- 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 Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)
- Where it went
- Nationwide within the USA
- How much
- 2,266 cartons
Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distr
D-0854-2021 · Class II · reported 2021-10-06 · Terminated
- Why it was recalled
- CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- Product
- 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: 60687-262-42
- Where it went
- Nationwide USA
- How much
- 548 ccases
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: Ame
D-0813-2021 · Class III · reported 2021-09-29 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- 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
- Where it went
- Nationwide within the USA
- How much
- 290 cartons
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister card
D-0232-2021 · Class II · reported 2021-01-27 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- 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 Blister Card: 68084- 446-11
- Where it went
- Nationwide USA
- How much
- 1948 cartons
Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed
D-1372-2020 · Class III · reported 2020-07-01 · Terminated
- Why it was recalled
- Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
- Product
- 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
- Where it went
- Nationwide USA
- How much
- 265 cartons
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American He
D-1293-2020 · Class II · reported 2020-06-17 · Terminated
- Why it was recalled
- Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
- Product
- 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
- Where it went
- USA Nationwide
- How much
- 15,755 cartons
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed
D-1003-2020 · Class II · reported 2020-03-18 · Terminated
- Why it was recalled
- CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
- Product
- 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: 60687-322-11
- Where it went
- Nationwide USA
- How much
- 53,619 cartons
Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distr
D-0848-2020 · Class II · reported 2020-02-26 · Terminated
- Why it was recalled
- GMP Deviations: Product bottle may be absent of desiccant.
- Product
- 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 68084-606-11
- Where it went
- Nationwide USA
- How much
- 1,879 cartons
Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distr
D-0849-2020 · Class II · reported 2020-02-26 · Terminated
- Why it was recalled
- GMP Deviations: Product bottle may be absent of desiccant.
- Product
- 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 68084-604-11
- Where it went
- Nationwide USA
- How much
- 3,720 cartons
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distrib
D-0854-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
- Product
- 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: 60687-266-11
- Where it went
- Nationwide within the United States
- How much
- 973 cartons
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: Amer
D-0631-2020 · Class II · reported 2020-01-08 · Terminated
- Why it was recalled
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Product
- 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 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
- Where it went
- Nationwide USA
- How much
- 1,692 cases of 40 and 50 cups
Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose
D-1847-2019 · Class III · reported 2019-09-18 · Terminated
- Why it was recalled
- 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.
- Product
- 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
- Where it went
- Nationwide
- How much
- 60 cartons
Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4
D-1820-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
- Product
- 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: 60687-305-32; NDC Blister Pack: 60687-305-33
- Where it went
- Nationwide USA
- How much
- 13,229 cartons
Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, D
D-1821-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- 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: 68084-562-11
- Where it went
- Nationwide USA
- How much
- 457 cartons
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (N
D-1584-2019 · Class III · reported 2019-08-14 · Terminated
- Why it was recalled
- CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
- Product
- 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.
- Where it went
- Nationwide within the USA and Puerto Rico
- How much
- 14,360 bottles
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distribu
D-1582-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Out of specification result for the dissolution test.
- Product
- 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: 62584-693-11
- Where it went
- Nationwide in the USA
- How much
- 6,579 cartons
Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx O
D-1467-2019 · Class II · reported 2019-07-17 · Terminated
- Why it was recalled
- GMP Deviations: Potential cross contamination due to cleaning procedure failure.
- Product
- 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
- Where it went
- Nationwide USA
- How much
- 375,921 bottles
Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed b
D-1431-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
- Product
- 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
- Where it went
- Nationwide USA
- How much
- 3,015 cartons
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by:
D-1434-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
- Product
- 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
- Where it went
- Nationwide USA
- How much
- 6,643 cartons
Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by:
D-1433-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
- Product
- 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
- Where it went
- Nationwide USA
- How much
- 8,777 cartons
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: Am
D-1432-2019 · Class II · reported 2019-07-03 · Terminated
- Why it was recalled
- GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
- Product
- 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
- Where it went
- Nationwide USA
- How much
- 16,698 cartons
Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by:
D-1394-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- GMP Deviations: Potential cross contamination due to cleaning procedure failure.
- Product
- 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.
- Where it went
- Nationwide within the USA
- How much
- 15,386 cartons
GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: Americ
D-1276-2019 · Class II · reported 2019-05-08 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
- Product
- 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
- Where it went
- Nationwide in the USA
- How much
- 2,203 cartons (cartons of 30 individual unit doses)
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed
D-1047-2019 · Class II · reported 2019-03-27 · Terminated
- Why it was recalled
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Product
- 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#: 60687-139-01)
- Where it went
- Nationwide USA and Puerto Rico
- How much
- 3337 cartons
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Ameris
D-0273-2019 · Class III · reported 2018-11-28 · Terminated
- Why it was recalled
- 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."
- Product
- 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 68084-446-01 (Individual Dose NDC: 68064-446-11)
- Where it went
- U.S.A. Nationwide
- How much
- 4508 blister packs
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged
D-0915-2018 · Class III · reported 2018-07-18 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
- Product
- 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 Dose]
- Where it went
- 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.
- How much
- 1285 cartons (cartons of 100 individual unit doses)
Showing the 30 most recent of 59. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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