American Family Pharmacy Recalls Subpotent Aspirin Tablets
American Family Pharmacy is recalling 4.2 million bottles of Assured Aspirin 81 mg tablets because they failed to meet USP specifications for potency and uniformity.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe; while no injuries are reported, the subpotent nature of a critical medication like aspirin warrants a high severity rating under the 'risk-of-harm' criteria, but the explicit Class II classification combined with the potential for therapeutic failure places it in the Severe category per the rubric's handling of significant defects.
Plain-English summary
American Family Pharmacy, LLC is recalling Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength. The recall involves 4,207,200 tablets distributed in 60-count bottles. The product is distributed by Greenbrier International, Inc., in Chesapeake, VA, and is identified by Lot #12084 with an expiration date of 05/16.
The FDA has classified this as a Class II recall because the product failed to meet United States Pharmacopeia (USP) specifications for assay, content uniformity, and dissolution. This means the tablets may not contain the correct amount of active ingredient or may not dissolve properly in the body.
The recalled product was distributed in Virginia, Washington, and California. Consumers who have this product should stop using it and contact their pharmacist or the recalling firm for a refund or replacement.
The recalled product
- Product
- Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.
- Manufacturer
- American Family Pharmacy, LLC
- Affected units
- 4,207,200
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#12084
- Exp. 05/16
Distribution
Related recalls
Same hazard · subpotent drug
See all →- LowImprimisRx Recalls Subpotent Povidone Iodine and Proparacaine Ophthalmic Solution
FDA (Drugs) · 2026-09-16
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
Similar recalls
- ModerateAspirin Products Recalled Due to Improper Storage Conditions at Family Dollar
FDA (Drugs) · 2022-08-31
- ModerateAdvance Formula Pain Reliever tablets recalled for failed stability specifications
FDA (Drugs) · 2021-11-03
- LowSmart Sense Aspirin Recalled for Incorrect Expiration Date Labeling
FDA (Drugs) · 2019-08-14
- ModeratePainAway II Acetaminophen/Aspirin/Caffeine Tablets Recalled for Failed Stability
FDA (Drugs) · 2021-11-03
- ModerateAspirin 81 mg chewable tablets recalled due to packaging defect
FDA (Drugs) · 2024-11-27
- ModerateXpect First Aid Extra Strength Pain Away tablets recalled for failed stability specifications
FDA (Drugs) · 2021-11-03