CLASS II Drug recall · Reported 22 Apr 2020 · FDA Enforcement Report
Acetaminophen and Codeine Phosphate recalled by H J Harkins Company
H J Harkins is recalling Acetaminophen and Codeine Phosphate 300, distributed in Arizona, California. The recall was initiated on 15 Apr 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-1246-2020
- FDA event ID
- 85482
- Recalling firm
- H J Harkins, Grover Beach, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Apr 2020
- FDA classified
- 16 Apr 2020
- Reported
- 22 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 15 Apr 2020 | Recall initiated by company | |
| 16 Apr 2020 | Classified by FDA | +1 day |
| 22 Apr 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
cGMP Deviations
Product as listed by the FDA
Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433
Where it was distributed
Product was distributed in CA and AZ.
Questions about this recall
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot # ATP12ZT, Exp. 05/21
Where was it sold?
Product was distributed in CA and AZ.
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 500 mg tablet packaged in a) 30-count bottles recalled | H J Harkins | Packaging Defects | Nationwide |
| 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 |