CLASS II Drug recall · Reported 3 Jul 2019 · FDA Enforcement Report
Diphenhydramine HCL Liquid, 12.5 mg recalled by H J Harkins Company
H J Harkins is recalling Diphenhydramine HCL Liquid, 12.5 mg, distributed nationwide in the US. The recall was initiated on 24 Jun 2019 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-1430-2019
- FDA event ID
- 83195
- Recalling firm
- H J Harkins, Grover Beach, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jun 2019
- FDA classified
- 27 Jun 2019
- Reported
- 3 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 24 Jun 2019 | Recall initiated by company | |
| 27 Jun 2019 | Classified by FDA | +3 days |
| 3 Jul 2019 | 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
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Where it was distributed
Nationwide Within the United States
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Which lots are affected?
Lot #: DHI56M, Exp. 12/19
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.
Other products in this recall event
1 other product · FDA event 83195This product is part of a recall event; the main page for the event is Acetaminophen Children's Liquid, 160 mg recalled by H J Harkins Company.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Acetaminophen Children's Liquid, 160 mg recalled by H J Harkins Company | H J Harkins | Sterility | Nationwide |
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 | 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 | Acetaminophen Children's Liquid, 160 mg recalled by H J Harkins Company | H J Harkins | Sterility | Nationwide |