Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Diphenhydramine HCL Liquid Recalled by H J Harkins Company Inc dba Pharma Pac Due to Microbial Contamination of Non-sterile Products: Potential product contamination...

Date: June 24, 2019
Company: H J Harkins Company Inc dba Pharma Pac
Status: Terminated
Source: FDA (Drug)

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

Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.

Quantity: 12 bottles

Why Was This Recalled?

Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About H J Harkins Company Inc dba Pharma Pac

H J Harkins Company Inc dba Pharma Pac has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report