CLASS II Drug recall · Reported 14 Sep 2022 · FDA Enforcement Report
Diphenhydramine HCl Oral Solution 12.5 mg / cup recalled
Plastikon Healthcare is recalling Diphenhydramine HCl Oral Solution 12.5 mg / cup, distributed nationwide in the US. The recall was initiated on 7 Jun 2022 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-1488-2022
- FDA event ID
- 90398
- Recalling firm
- Plastikon Healthcare, Lawrence, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2022
- FDA classified
- 6 Sep 2022
- Reported
- 14 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Allergy Medication
Timeline
| 7 Jun 2022 | Recall initiated by company | |
| 6 Sep 2022 | Classified by FDA | +91 days |
| 14 Sep 2022 | Published in enforcement report | +8 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: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product as listed by the FDA
Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Which lots are affected?
Lot # 20063A, EXP Jun. 2022; 20098A, EXP Oct. 2022; 21055B, EXP May. 2023; 21066A, EXP Jun. 2023; 21083B, EXP Jul. 2023; 21112B, EXP Oct. 2023; 22009A, EXP Feb. 2024.
Where was it sold?
Distributed Nationwide in the USA
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
18 other products · FDA event 90398More recalls from Plastikon Healthcare
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Guaifenesin And Dextromethorphan 200-20 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg recalled | Plastikon Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Guaifenesin And Dextromethorphan 100 mg-10 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Correctdose Children's Cough & Chest Congestion DM recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Diphenhydramine recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diphenhydramine 18mg in NS Syringe, antihistamine recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Diphenhydramine HCl Oral Solution, 25 mg / cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diphenhydramine HCl oral solution, USP, 25 mg/ UD recalledDiphenhydramine Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Banophen Diphenhydramine HCl 25 mg Antihistamine recalledDiphenhydramine Hydrochloride | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Diphenhydramine 25 MG/ Ns recalled by Infusion Options | Infusion Options | Sterility | NY |