CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Acetaminophen, Regular Strength Pain Reliever recalled
Spirit Pharmaceuticals is recalling Acetaminophen, Regular Strength Pain Reliever, distributed nationwide in the US. The recall was initiated on 16 Jun 2021 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-0729-2021
- FDA event ID
- 88322
- Recalling firm
- Spirit Pharmaceuticals, Ronkonkoma, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2021
- FDA classified
- 16 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 16 Jun 2021 | Recall initiated by company | |
| 16 Aug 2021 | Classified by FDA | +61 days |
| 25 Aug 2021 | Published in enforcement report | +9 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: Discolored acetaminophen
Product as listed by the FDA
Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
Where it was distributed
USA Nationwide
Stores named: Walmart
Questions about this recall
Why was it recalled?
cGMP deviations: Discolored acetaminophen
Which lots are affected?
Lot #: S210240, Exp. 03/2023
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.
More recalls from Spirit Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ibuprofen Tablets USP, 200 mg recalled by Spirit PharmaceuticalsValumeds Ibuprofen | Spirit Pharmaceuticals | Manufacturing (CGMP) Deviations | NY |