Class II · Moderate risk
Diphenhydramine HCl oral solution
cGMP deviations: Temperature abuse
National Drug Code
Is NDC 0121-0978-00 recalled?
Diphenhydramine Hydrochloride · 10 TRAY in 1 CASE (0121-0978-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0978-10)
Yes — this exact package was recalled
1 FDA recall names the code 0121-0978-00 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Diphenhydramine Hydrochloride
- Strength
- DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL
- Form
- Solution · Oral
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Type
- Human Prescription Drug
- Product code
- 0121-0978
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.