CLASS II Drug recall · Reported 21 Jun 2017 · FDA Enforcement Report
Acetaminophen 325mg tablets, Pk By Safecor Health Woburn, MA recalled
Safecor Health is recalling Acetaminophen 325mg tablets, Pk By Safecor Health Woburn, MA 01801, distributed in Massachusetts, New York. The recall was initiated on 7 Jul 2016 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-0900-2017
- FDA event ID
- 74822
- Recalling firm
- Safecor Health, Woburn, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2016
- FDA classified
- 12 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 7 Jul 2016 | Recall initiated by company | |
| 12 Jun 2017 | Classified by FDA | +340 days |
| 21 Jun 2017 | 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
Product as listed by the FDA
Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.
Where it was distributed
MA and NY
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: A18688, Exp. 09/30/2018
Where was it sold?
MA and NY
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
5 other products · FDA event 74822This product is part of a recall event; the main page for the event is Calcium Carbonate 600mg/Vitamin D recalled by Safecor Health.
More recalls from Safecor Health
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|---|---|---|---|---|---|
| Drug | CLASS II | Vitamin B-Complex, Vitamin C & Folic Acid Dietary recalled | Safecor Health | Particulate Matter | OH |
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| 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 Acetaminophen recalls
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |