Amazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration
Aurobindo Pharma USA Inc is recalling Amazon Basic Care Acetaminophen 325 mg tablets due to confirmed consumer complaints of brown surface discoloration on tablets, a cGMP deviation.
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 an FDA Class II recall with a manufacturing process deviation (cGMP deviation) indicated by tablet discoloration. No illnesses or injuries have been reported in the source text. The hazard is primarily a quality/labeling concern rather than a direct health threat, making this a Moderate severity case.
Plain-English summary
Aurobindo Pharma USA Inc is recalling Amazon Basic Care Acetaminophen 325 mg tablets (100-count bottles) distributed nationwide by Amazon.com Services LLC. The recall is due to confirmed consumer complaints of tablet discoloration, with brown discoloration observed on tablet surfaces. The affected product is Lot #AEF124004A with an expiration date of 08/31/2026.
This discoloration represents a cGMP (current Good Manufacturing Practice) deviation. Consumers who have purchased this product should stop using it and consult a pharmacist or healthcare provider with questions. The distributor is working with the FDA to ensure the product is removed from commerce.
The recalled product
- Product
- AMAZON BASIC CARE ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- AMAZON BASIC CARE ACETAMINOPHEN
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug — OTC Analgesic
- Affected units
- 4,608
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 (2)
- Lot#: AEF124004A
- Exp date 08/31/2026
UPCs (1)
- 0195515048866
Distribution
Distributed nationwide across the United States.
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