Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Impurity Failure
Morton Grove Pharmaceuticals is recalling Prednisolone Sodium Phosphate Oral Solution because it failed impurity specifications for Prednisolone Impurity 14.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Morton Grove Pharmaceuticals, Inc. is recalling Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in 8 fl oz (237 mL) bottles. The product is prescription-only and was distributed nationwide in the United States and Puerto Rico.
The recall was initiated because the product failed impurity/degradation specifications, specifically for Prednisolone Impurity 14. The affected lots are US1450 (Exp 10/31/19), US1570 (Exp 12/31/19), UT1018 (Exp 1/31/19), UT1173 (Exp 6/30/20), UT1348, and UT1354 (Exp 8/31/20). A total of 196,408 bottles are involved in this recall.
The FDA has classified this recall as Class II. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal or credit.
The recalled product
- Product
- Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 196,408
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 (11)
- Lot #: US1450
- Exp 10/31/19
- US1570
- Exp 12/31/19
- UT1018
- Exp 1/31/19
- UT1173
- Exp 6/30/20
- UT1348
- UT1354
- Exp 8/31/20
Distribution
Related recalls
Same manufacturer · Morton Grove Pharmaceuticals, Inc.
See all →- ModerateDexamethasone Elixir Recalled for Impurities Above Permissible Levels
FDA (Drugs) · 2022-03-09
- ModeratePromethazine Syrup Plain Recall Due to Microbial Contamination
FDA (Drugs) · 2021-09-29
- HighPromethazine With Codeine Oral Solution Recall Due to Microbial Contamination
FDA (Drugs) · 2021-09-29
- ModerateValproic Acid Oral Solution recalled for microbial contamination
FDA (Drugs) · 2021-09-29
- SevereMorton Grove Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities
FDA (Drugs) · 2020-12-30
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17