Acetaminophen 325 mg Tablets Recalled Due to Manufacturing Deviations
ULTRAtab Laboratories is recalling Coated APAP 325mg acetaminophen tablets sold in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects approximately 16.4 million tablets distributed to three wholesalers.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II drug recall initiated voluntarily by the manufacturer for CGMP deviations. No reported illnesses, injuries, or deaths are stated in the source text. The hazard is manufacturing-process related rather than a confirmed contamination or high-risk pathogen, placing it at Moderate severity.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Coated APAP 325mg (Acetaminophen 325 mg) tablets in bulk container format. The recall involves product with NDC 62959-202-00 and affects bulk lots 18K013, 18K014, 18K015, 19A040, 18M076, 19A041, 19H072, 19H073, and 19H074, with approximately 16,429,211 tablets involved.
The recall was initiated due to CGMP Deviations in the manufacturing process. The bulk product was distributed to three distributors, who may have distributed finished products made from this material to further customers.
Consumers or healthcare providers who have this product should contact their supplier or distributor for instructions on return or disposal. This is a Class II recall, meaning the defect could cause adverse health consequences or death, though no specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Tablet / Bulk Container
- Affected units
- 16,429,211
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Product Codes: L202L Bulk Lots: 18K013
- 18K014
- 18K015
- 19A040
- 18M076
- 19A041
- 19H072
- 19H073
- 19H074
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 33 recalled by ULTRAtab Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 33 products in this recall →Related recalls
Same manufacturer · ULTRAtab Laboratories, Inc.
See all →- ModerateDBI Magnums Caffeine Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModerateHPC Tablet Drug Recalled Due to CGMP Manufacturing Deviations
FDA (Drugs) · 2022-02-16
- ModerateMelatonin ER supplement recalled for manufacturing practice deviations
FDA (Food) · 2022-02-16
- ModerateDietary supplement melatonin recall due to manufacturing deviations
FDA (Food) · 2022-02-16
- Moderate
Same hazard · cgmp deviation
See all →- ModeratePritam International Recalls Brush Buddies Toothpaste Due to CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModerateARU Toothpaste Recalled for CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls Brush Buddies Fluoride Toothpaste for CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls Brush Buddies Toothpaste Due to CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls My Little Pony Toothpaste for CGMP Deviations
FDA (Drugs) · 2026-10-28
Similar recalls
- ModerateSafecor Health Recalls Acetaminophen Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2017-06-21
- ModerateCaffeine dietary supplement recalled due to manufacturing practice deviations
FDA (Food) · 2022-02-16
- ModeratePain Aid ESF Bulk Tablets Recall Due to Manufacturing Process Failures
FDA (Drugs) · 2022-01-12
- ModerateCetafen acetaminophen tablets recalled for manufacturing deviations
FDA (Drugs) · 2022-02-09
- ModerateMarlex Acetaminophen Tablets Recalled for Manufacturing Practice Deviations
FDA (Drugs) · 2013-10-09
- ModerateAYPANAL Pain Reliever Tablets Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-09