Morton Grove Recalls Promethazine With Codeine Oral Solution Due to CGMP Deviations
Morton Grove Pharmaceuticals recalls 14,904 bottles of Promethazine With Codeine Oral Solution due to potential microbial contamination from contaminated sugar batches.
Recall notice
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Contact the company
What happened, in plain English
Morton Grove Pharmaceuticals, Inc. is recalling one lot of Promethazine With Codeine Oral Solution because of Current Good Manufacturing Practice (CGMP) deviations. The concern is that the liquid sugar batches used in manufacturing may have been contaminated with microbial organisms. The record does not specify a remedy or action for consumers. Read more at govinfonow.com/recall/35862-morton-grove-recalls-promethazine-with-codeine-oral-solution-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/35862-morton-grove-recalls-promethazine-with-codeine-oral-solution-due-to · Updated October 10, 2026 · FDA enforcement record: FDA #D-0815-2021
Cite this page
“Morton Grove Recalls Promethazine With Codeine Oral Solution Due to CGMP Deviations.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35862-morton-grove-recalls-promethazine-with-codeine-oral-solution-due-to. Based on FDA recall #D-0815-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0815-2021%22&limit=1).
Why it’s dangerous
The hazard stems from potential microbial contamination in the liquid sugar batches used during manufacturing. This CGMP deviation raises a concern about product safety, though the record does not detail specific injuries or health outcomes.
Who’s affected
Patients who were prescribed Promethazine With Codeine Oral Solution and purchased the specific lot UV1198 are affected. The product was distributed nationwide in the USA and to China.
How to tell if you have this one
Check if you have Promethazine With Codeine Oral Solution (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL) in a 1 Pint (473 mL) bottle. Look for NDC: 60432-606-16 and Lot #: UV1198. The product is Rx Only and manufactured by Morton Grove Pharmaceuticals, Inc.
- Brand
Morton Grove Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Completed- Distribution
Nationwide USA and China
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0814-2021 | Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 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: 60432-608-16; Lot #: UV1335; UV1352; and UV1373 | 116,400 bottles |
| D-0815-2021 | 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; Lot #: UV1198 | 14,904 bottles |
| D-0816-2021 | Valproic Acid Oral Solution USP, (250 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: 60432-621-16; Lot #: UV1159 | 38,748 bottles |
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide USA and China” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 26 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product sold?
The distribution pattern includes nationwide USA and China.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0815-2021 (September 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0815-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.