CLASS II ONGOING Drug recall · Reported 27 Nov 2024 · FDA Enforcement Report
Aspirin Chewable tablet 81 mg recalled by Safecor Health
Safecor Health is recalling Aspirin Chewable tablet 81 mg in blister card-foils unit dose, www.safecorhealth.com, distributed nationwide in the US. The recall was initiated on 11 Nov 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0058-2025
- FDA event ID
- 95659
- Recalling firm
- Safecor Health, Woburn, MA
- Brand
- Aspirin
- Manufacturer
- Safecor Health, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Nov 2024
- FDA classified
- 19 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 11 Nov 2024 | Recall initiated by company | |
| 19 Nov 2024 | Classified by FDA | +8 days |
| 27 Nov 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Product as listed by the FDA
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Which lots are affected?
Lot# 24A0061, exp. date 05/23/2026
Where was it sold?
USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 95659| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Calcium Carbonate Chewable 500 mg recalled by Safecor HealthCalcium Antacid | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Docusate Sodium 250 mg in blister card-foils unit dose recalled | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Vitamin B1, 100 mcg in blister card-foils unit dose recalled | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Vitamin D3, 25 mcg in blister card-foils unit dose recalled | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Safecor Health
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vitamin B-Complex, Vitamin C & Folic Acid Dietary recalled | Safecor Health | Particulate Matter | OH |
| Drug | CLASS II | Atomoxetine Capsules HCL in unit dose foil strip, strips recalledAtomoxetine | Safecor Health | Labeling Errors | TX |
| Drug | CLASS II | Haloperidol Lactate Injection, 5 mg/mL recalled by Safecor HealthHaloperidol Lactate | Safecor Health | Packaging Defects | MA |
| Drug | CLASS II | Simethicone 20 mg per Oral Syringe, Delivers:, Oral Drops recalled | Safecor Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Morphine Sulfate 5 mg per Oral Syringe, Delivers:, Oral Solution recalled | Safecor Health | Packaging Defects | Nationwide |
Other Aspirin recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Low Dose Aspirin, 81 mg recalled by Cardinal HealthcareAspirin | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Aspirin and Extended-release Dipyridamole Capsules recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Aspirin Chewable Tablets, 81 mg, (Nsaid*) recalled | Mckesson Packaging Services | Foreign Material | Nationwide |
| Drug | CLASS II | Aspirin/ER Dipyridamole, Capsule, 25 mg/200 mg recalled | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Aspirin, Chew Tablet, 81 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |