CLASS II Drug recall · Reported 8 Mar 2017 · FDA Enforcement Report
HealthA2Z Chewable Aspirin (Nsaid) 81 mg, Orange Flavor, a) recalled
Allegiant Health is recalling HealthA2Z Chewable Aspirin (Nsaid) 81 mg, Orange Flavor, a), distributed nationwide in the US. The recall was initiated on 16 Feb 2017 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-0500-2017
- FDA event ID
- 76495
- Recalling firm
- Allegiant Health, Deer Park, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Feb 2017
- FDA classified
- 28 Feb 2017
- Reported
- 8 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 16 Feb 2017 | Recall initiated by company | |
| 28 Feb 2017 | Classified by FDA | +12 days |
| 8 Mar 2017 | 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 - presence of rubber particles found loose in the bulk product.
Product as listed by the FDA
HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
cGMP deviations - presence of rubber particles found loose in the bulk product.
Which lots are affected?
Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)
Where was it sold?
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.
More recalls from Allegiant Health
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | col-rite (docusate sodium) stool softener softgels, 50 mg recalled | Allegiant Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Famotidine Tablets, USP, Over the Counter recalled by Allegiant Health | Allegiant Health | Manufacturing (CGMP) Deviations | Nationwide |