Afassco Pain Free Plus X-Strength Tablets Recalled for Failed Stability
Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets nationwide due to out-of-specification results for Salicylic Acid, a related compound of Aspirin, indicating failed stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III recall with no reported illnesses or injuries. The hazard is a failed stability specification for an aspirin-related compound, which represents a precautionary concern rather than an immediate safety threat with reported harm.
Plain-English summary
Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets (containing Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg) due to failed stability specifications. Testing revealed out-of-specification results for Salicylic Acid, which is a compound related to Aspirin in the product.
The affected product consists of 519,600 tablets packaged in 2-tablet packets, distributed nationwide in the USA. The specific lot recalled is Lot #9819 or K-9819, with an expiration date of September 22.
Consumers who have purchased this product should stop using it and consult with their healthcare provider or pharmacist if they have any concerns about their health. The product should not be used.
The recalled product
- Product
- Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Pain Reliever Tablets
- Affected units
- 519,600
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 (3)
- Lot #: 9819
- K-9819
- exp. date 22-Sep
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Ultra Seal Corporation 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.
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