CLASS II Drug recall · Reported 18 Mar 2020 · FDA Enforcement Report
Acetaminophen 500 mg tablet packaged in a) 30-count bottles recalled
H J Harkins is recalling Acetaminophen 500 mg tablet packaged in a) 30-count bottles (, distributed nationwide in the US. The recall was initiated on 6 Mar 2020 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-1005-2020
- FDA event ID
- 85158
- Recalling firm
- H J Harkins, Grover Beach, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2020
- FDA classified
- 12 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 6 Mar 2020 | Recall initiated by company | |
| 12 Mar 2020 | Classified by FDA | +6 days |
| 18 Mar 2020 | 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
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Which lots are affected?
Lot #: AE00M, exp. date 08/2021
Where was it sold?
Nationwide within the United States
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 H J Harkins
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetaminophen and Codeine Phosphate recalled by H J Harkins Company | H J Harkins | Manufacturing (CGMP) Deviations | AZ, CA |
| Drug | CLASS II | Ranitidine, a), b), c), d), e) recalled by H J Harkins Company | H J Harkins | Nitrosamine Impurity | 4 states |
| Drug | CLASS II | Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g recalled | H J Harkins | Manufacturing (CGMP) Deviations | CA |
| Drug | CLASS II | Diphenhydramine HCL Liquid, 12.5 mg recalled by H J Harkins Company | H J Harkins | Sterility | Nationwide |
| Drug | CLASS II | Acetaminophen Children's Liquid, 160 mg recalled by H J Harkins Company | H J Harkins | Sterility | Nationwide |