H J Harkins Company Inc dba Pharma Pac recalls Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count
Pharma Pac recalls acetaminophen-codeine tablets due to cGMP deviations. Products sold in 10-60 count bottles with specific NDC numbers. No remedy provided in official notice.
Recall notice
cGMP Deviations
Contact the company & request your remedy
What happened, in plain English
Pharma Pac is recalling acetaminophen and codeine phosphate tablets that were manufactured with cGMP deviations. This recall affects specific bottle sizes and quantities, but no safety remedy is listed in the official notice. Read more at govinfonow.com/recall/37144-pharma-pac-acetaminophen-codeine-tablets-recall-cpg-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/37144-pharma-pac-acetaminophen-codeine-tablets-recall-cpg-deviations · Updated October 5, 2026 · FDA enforcement record: FDA #D-1246-2020
Cite this page
“Pharma Pac Acetaminophen-Codeine Tablets Recall: CPG Deviations.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37144-pharma-pac-acetaminophen-codeine-tablets-recall-cpg-deviations. Based on FDA recall #D-1246-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1246-2020%22&limit=1).
Why it’s dangerous
The recall is due to cGMP deviations, which are quality control issues in manufacturing. These deviations could potentially affect the safety and effectiveness of the medication, though the exact nature of the problem isn't specified in the notice.
Who’s affected
People who own or use the recalled acetaminophen-codeine tablets in the specified bottle sizes. Those with prescription medication for pain or cough may be at risk if they have the affected products.
How to tell if you have this one
Check for bottles labeled with 10-60 count sizes and the NDC numbers 52959-0003-10 through 52959-0003-60. The products are prescription-only and were manufactured by Aurobindo and repackaged by H.J. Harkins Co., Inc.
- Brand
Pharma Pac- Category
Drug
What to do — step by step
Check Product Labels
Look for bottles with 10-60 count sizes and the specific NDC numbers listed in the recall notice.
Questions people ask
Is there a remedy for this recall?
The official notice does not provide a remedy or action steps for affected products.
What is the specific hazard with these tablets?
The recall is due to cGMP deviations, which are quality control issues that may affect the safety and effectiveness of the medication.
How can I tell if I have the recalled product?
Check for bottles with 10-60 count sizes and the NDC numbers 52959-0003-10 through 52959-0003-60.
Contact Pharma Pac
We’ve drafted a message you can send Pharma Pac to request your refund or repair — edit it as you like.
Subject: Recall D-1246-2020 — Pharma Pac Pharma Pac Hello, I own a Pharma Pac that is covered by recall D-1246-2020 from Pharma Pac. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1246-2020 (April 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1246-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.