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Amerisource Health Services LLC
Amerisource Health Services LLC: 46 FDA recall reports
Every drug recall the FDA has published for Amerisource Health Services LLC. The fault, and how the agency graded it.
46Reports
1Class I
31Ongoing
2026-05-27Most recent
1 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.
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: Am
D-0537-2026 · Class III · reported 2026-05-27 · Ongoing
- Why it was recalled
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
- Where it went
- USA Nationwide
- How much
- 225,000 tablets
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: A
D-0536-2026 · Class III · reported 2026-05-27 · Ongoing
- Why it was recalled
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Product
- Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
- Where it went
- USA Nationwide
- How much
- 63,500 tablets
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individua
D-0418-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- Failed tablet specifications.
- Product
- Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.
- Where it went
- U.S. Nationwide
- How much
- 697 cartons
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The
D-0338-2026 · Class II · reported 2026-02-18 · Ongoing
- Why it was recalled
- Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
- Product
- Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
- Where it went
- Nationwide in the USA
- How much
- 31,676 packages
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Healt
D-0103-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
- Product
- Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33
- Where it went
- Nationwide within the United States
- How much
- 3,410 cartons
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American He
D-0102-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
- Product
- Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11
- Where it went
- Nationwide within the United States
- How much
- 1,818 cartons
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American He
D-0101-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
- Product
- Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
- Where it went
- Nationwide within the United States
- How much
- 1,970 cartons
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Colu
D-0027-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Product
- Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
- Where it went
- Nationwide within the United States
- How much
- 27,868 blister packs
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, Ame
D-0675-2025 · Class II · reported 2025-10-08 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications.
- Product
- Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
- Where it went
- Nationwide in the USA.
- How much
- 360 cartons
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by
D-0650-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
- Where it went
- Nationwide in the USA
- How much
- 873 cartons
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American
D-0648-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
- Where it went
- Nationwide in the USA
- How much
- 1,062 cartons
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by
D-0649-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
- Where it went
- Nationwide in the USA
- How much
- 1,757 cartons
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (I
D-0647-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
- Where it went
- Nationwide in the USA
- How much
- 2,708 cartons
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Colu
D-0598-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Product
- Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
- Where it went
- Nationwide
- How much
- 26,992 blister packs
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Di
D-0454-2025 · Class II · reported 2025-06-11 · Ongoing
- Why it was recalled
- cGMP deviations
- Product
- Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).
- Where it went
- Nationwide in the USA
- How much
- 21 cartons
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Th
D-0368-2025 · Class II · reported 2025-04-30 · Ongoing
- Why it was recalled
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Product
- Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
- Where it went
- Nationwide in the USA
- How much
- 14,189 vials
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Th
D-0369-2025 · Class II · reported 2025-04-30 · Ongoing
- Why it was recalled
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Product
- Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
- Where it went
- Nationwide in the USA
- How much
- 143 1x5 vials
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeut
D-0367-2025 · Class II · reported 2025-04-30 · Ongoing
- Why it was recalled
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Product
- Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
- Where it went
- Nationwide in the USA
- How much
- 2,110 vials
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Uni
D-0307-2025 · Class II · reported 2025-04-09 · Terminated
- Why it was recalled
- cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
- Product
- Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.
- Where it went
- USA nationwide.
- How much
- 889 cartons
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: Am
D-0202-2025 · Class II · reported 2025-01-22 · Terminated
- Why it was recalled
- Failed Dissolution Specifications:
- Product
- glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
- Where it went
- Nationwide in the USA
- How much
- 2,028 units (cartons of 30 individual unit doses)
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmace
D-0201-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- Presence of Foreign Tablets/Capsules
- Product
- Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
- Where it went
- Nationwide within the United States
- How much
- 4640 units
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmace
D-0184-2025 · Class II · reported 2025-01-15 · Ongoing
- Why it was recalled
- Presence of Foreign Tablets/Capsules
- Product
- Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21
- Where it went
- Nationwide within the United States
- How much
- 5,178 cartons
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma
D-0156-2025 · Class II · reported 2025-01-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
- Where it went
- Nationwide in the USA
- How much
- 13,678 bottles
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma L
D-0155-2025 · Class II · reported 2025-01-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
- Product
- Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
- Where it went
- Nationwide in the USA
- How much
- 21,262 bottles
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma L
D-0157-2025 · Class II · reported 2025-01-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
- Product
- Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
- Where it went
- Nationwide in the USA
- How much
- 20,734 30-count bottles
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Phar
D-0158-2025 · Class II · reported 2025-01-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
- Where it went
- Nationwide in the USA
- How much
- 1,815 bottles
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharm
D-0101-2025 · Class II · reported 2024-12-11 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
- Where it went
- PA, OH, PR
- How much
- 8,561 bottles
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (N
D-0100-2025 · Class II · reported 2024-12-11 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
- Where it went
- PA, OH, PR
- How much
- 23,490 bottles
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma
D-0099-2025 · Class II · reported 2024-12-11 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- Product
- Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
- Where it went
- PA, OH, PR
- How much
- 37,916 bottles
Class I
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00),
D-0619-2024 · Class I · reported 2024-08-07 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
- Where it went
- US Nationwide.
- How much
- 61,231 bottles
Showing the 30 most recent of 46. 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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