CLASS II Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report
Promethazine With Codeine Oral Solution recalled
Morton Grove Pharmaceuticals is recalling Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/ & Codeine, distributed nationwide in the US. The recall was initiated on 3 Sep 2021 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-0815-2021
- FDA event ID
- 88629
- Recalling firm
- Morton Grove Pharmaceuticals, Morton Grove, IL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 3 Sep 2021
- FDA classified
- 20 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 3 Sep 2021 | Recall initiated by company | |
| 20 Sep 2021 | Classified by FDA | +17 days |
| 29 Sep 2021 | Published in enforcement report | +9 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: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Product as listed by the FDA
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16
Where it was distributed
Nationwide USA and China
Questions about this recall
Why was it recalled?
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Which lots are affected?
Lot #: UV1198
Where was it sold?
Nationwide USA and China
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 21 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
2 other products · FDA event 88629| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Valproic Acid Oral Solution USP, (250 mg/, 1 Pint recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Promethazine Syrup Plain, 6.25 mg recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Morton Grove Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Elixir, USP 0.5 mg/, Net recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Promethazine Syrup Plain, 6.25 mg recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Valproic Acid Oral Solution USP, (250 mg/, 1 Pint recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Prednisolone Sodium Phosphate Oral Solution, 15 mg recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |