CLASS II Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report
Aspirin and Extended-release Dipyridamole Capsules recalled
American Health Packaging is recalling Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg per carton (5 blister, distributed nationwide in the US. The recall was initiated on 1 Mar 2019 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-1820-2019
- FDA event ID
- 83479
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2019
- FDA classified
- 15 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 1 Mar 2019 | Recall initiated by company | |
| 15 Aug 2019 | Classified by FDA | +167 days |
| 21 Aug 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Which lots are affected?
Lot, expiry: Lot 174262, exp. 03/31/2019; Lot 176469, exp. 06/30/2019; Lot 177897, exp. 08/31/2019; Lots 178318 and 178436, exp. 09/30/2019; Lot 179547 and 179656, exp. 11/30/2019
Where was it sold?
Nationwide USA
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 American Health Packaging
All 60| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | Nationwide |
Other Aspirin recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Aspirin Chewable tablet 81 mg recalled by Safecor HealthAspirin | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Low Dose Aspirin, 81 mg recalled by Cardinal HealthcareAspirin | Cardinal Healthcare | Manufacturing (CGMP) Deviations | 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 |