Rugby Enteric Coated Aspirin 81 mg Recalled for Labeling Error
Advance Pharmaceutical Inc. is recalling 16,440 bottles of Enteric Coated Aspirin 81 mg due to a label mix-up where one bottle contained Acetaminophen 500 mg.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Advance Pharmaceutical Inc. is recalling 16,440 bottles of Enteric Coated Aspirin 81 mg, 120-count tablets, distributed by Rugby Laboratories, Inc. The recall is due to a labeling error where a pharmacist reported that one bottle labeled as Enteric Coated Aspirin 81 mg actually contained Acetaminophen 500 mg tablets.
The affected product is identified by Lot # 13A026 and an expiration date of 01/15. The product was distributed nationwide. The NDC is 0536-3086-41 and the UPC is 3 0536-3086-41 9.
Consumers should check their medication for this specific lot number and expiration date. If they have the affected product, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.
- Manufacturer
- Advance Pharmaceutical Inc
- Hazard
- Affected units
- 16,440
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 #: 13A026
- Exp 01/15
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Advance Pharmaceutical Inc
See all →- CriticalRugby Natural Iron Supplement Recalled for Labeling Error
FDA (Drugs) · 2013-06-19
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02