Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Acetaminophen and Codeine Phosphate 300/30 mg tablet Recalled by H J Harkins Company Inc dba Pharma Pac Due to cGMP Deviations
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact H J Harkins Company Inc dba Pharma Pac directly.
Affected Products
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
Quantity: 9,000 tablets
Why Was This Recalled?
cGMP Deviations
Where Was This Sold?
This product was distributed to 2 states: AZ, CA
About H J Harkins Company Inc dba Pharma Pac
H J Harkins Company Inc dba Pharma Pac has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report