The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1489-2022·Announced 2022-09-14

Diphenhydramine HCl Oral Solution Recalled for Manufacturing Process Deviations

Plastikon Healthcare LLC is recalling 349,100 cups of Diphenhydramine HCl Oral Solution due to manufacturing process control deviations. The product was distributed nationwide for institutional use only.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall due to manufacturing process control deviations. Although no illnesses or injuries have been reported, the potential quality risks from inadequate manufacturing controls place this in the category of 'risk-of-harm products where injury has not yet been reported' per the rubric.

Plain-English summary

Plastikon Healthcare LLC is recalling 349,100 cups of Diphenhydramine HCl Oral Solution, 25 mg/10 mL (NDC 0904-6741-72). The product was distributed nationwide in the United States for institutional use only and is packaged in 10 mL cups.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturing processes used to produce this product were not adequately controlled, which could affect product quality and safety.

The affected lot numbers are 20065A (expiration June 2022), 20068A and 20070A (July 2022), 20097A and 20098A (October 2022), 21055A (May 2023), 21083A (July 2023), 21091A (August 2023), and 21112A (October 2023).

This is an FDA Class II drug recall. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 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 0904-6741-72
Manufacturer
Plastikon Healthcare LLC
Category
Drug — Antihistamine / Oral Solution
Hazard
Affected units
349,100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • Lot # 20065A
  • EXP Jun. 2022
  • 20068A
  • 20070A
  • EXP Jul. 2022
  • 20097A
  • 20098A
  • EXP Oct. 2022
  • 21055A
  • EXP May. 2023
  • 21083A
  • EXP Jul. 2023
  • 21091A
  • EXP Aug. 2023
  • 21112A
  • EXP Oct. 2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Plastikon Healthcare LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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