Acetaminophen 325 mg tablets recalled for discoloration and cGMP deviations
Spirit Pharmaceuticals is recalling Acetaminophen 325 mg Regular Strength Pain Reliever tablets due to discoloration and current good manufacturing practice (cGMP) deviations. The recall affects one lot distributed nationwide.
What this means for you
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 involving a manufacturing deviation (discoloration) with no reported illnesses or injuries. The hazard is regulatory/quality-based rather than an immediate safety threat, placing it in the Moderate category.
Plain-English summary
Spirit Pharmaceuticals is recalling Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, sold in 100-count bottles and distributed by Walmart Inc. The recall applies to Lot #S210240 with an expiration date of 03/2023 (NDC 79903-052-10).
The recall was initiated due to discoloration of the acetaminophen tablets and deviations from current good manufacturing practice (cGMP) standards. No specific illnesses or injuries related to this recall have been reported in the source material.
Affected consumers should stop using this product and contact their pharmacy or healthcare provider with questions. Consumers may also return the product to the place of purchase or contact Spirit Pharmaceuticals or Walmart for further instructions.
The recalled product
- Product
- Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
- Manufacturer
- Spirit Pharmaceuticals
- Hazard
- discoloration
- cgmp-deviation
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 #: S210240
- Exp. 03/2023
Distribution
Distributed nationwide across the United States.
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