CLASS I Drug recall · Reported 6 Apr 2022 · FDA Enforcement Report
Meclizine Hydrochloride Tablets USP, 12.5 mg recalled
Jubilant Cadista Pharmaceuticals is recalling Meclizine Hydrochloride Tablets USP, 12.5 mg, distributed in Arkansas, Florida, North Carolina, Ohio, South Carolina. The recall was initiated on 8 Mar 2022 and the FDA has classified it as Class I.
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-0767-2022
- FDA event ID
- 89854
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Salisbury, MD
- Manufacturer
- Jubilant Cadista Pharmacuticals Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 Mar 2022
- FDA classified
- 12 Apr 2022
- Reported
- 6 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
Timeline
| 8 Mar 2022 | Recall initiated by company | |
| 6 Apr 2022 | Published in enforcement report | +29 days |
| 12 Apr 2022 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Product as listed by the FDA
Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06
Where it was distributed
Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
Questions about this recall
Why was it recalled?
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Which lots are affected?
Lot # 22P0036, Exp 12/2024
Where was it sold?
Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
More recalls from Jubilant Cadista Pharmaceuticals
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|---|---|---|---|---|---|
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| Drug | CLASS III | Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Donepezil HCL Tablets, USP, 5 mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
Other Meclizine Hydrocloride recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Meclizine hydrochloride tablets USP, 12.5 mg HDPE recalledMeclizine Hydrochloride | Jubilant Cadista Pharmaceuticals | Other | Nationwide |