Ohm Laboratories Recalls Loratadine and Pseudoephedrine Sulfate Tablets Due to Blister Defects
Ohm Laboratories is recalling 29,790 blister packs of Loratadine and Pseudoephedrine Sulfate Extended Release Tablets due to unacceptable blister defects.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to packaging defects (blister defects) which are typically associated with minor labeling or packaging issues that may cause temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria.
Plain-English summary
Ohm Laboratories, Inc. is recalling 29,790 blister packs of Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg. The recall was initiated because an unacceptable level of blister defects was identified in the product.
The affected product is distributed under various brand names, including CVS Allergy Relief - D, Discount Drug Mart, Kroger, Sunmark, Good Neighbor Pharmacy, H-E-B, and Rite Aid. The specific lots involved are # 2554936 and # 2554938, with an expiration date of 09/15. The product was distributed in California, Ohio, Pennsylvania, Rhode Island, and Texas.
Consumers who have purchased these specific lots should stop using the product and contact their pharmacist or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LORATADINE AND PSEUDOEPHEDRINE SULFATE (LORATADINE AND PSEUDOEPHEDRINE SULFATE)
- Brand
- LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Manufacturer
- Ohm Laboratories, Inc.
- Hazard
- Affected units
- 29,790
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 (3)
- Lot # 2554936
- 2554938
- Exp 09/15
UPCs (3)
- 050428049631
- 093351116285
- 011822331555
Distribution
Related recalls
Same brand · LORATADINE AND PSEUDOEPHEDRINE SULFATE
- ModerateLoratadine-D Extended-Release Tablets Recalled for Failed Moisture Limits
FDA (Drugs) · 2021-11-03
Same manufacturer · Ohm Laboratories, Inc.
See all →- ModerateQC Quality Choice Loratadine Tablets Recalled for Out-of-Specification Assay
FDA (Drugs) · 2015-10-21
- LowCVS Loratadine Tablets Recalled for Out-of-Specification Assay Results
FDA (Drugs) · 2015-10-21
- ModerateOhm Laboratories Recalls Loratadine Tablets Due to Potency Issues
FDA (Drugs) · 2015-10-21
- ModerateOhm Laboratories Recalls Loratadine Tablets Due to Out-of-Specification Assay
FDA (Drugs) · 2015-10-21
- ModerateOhm Recalls HEB Loratadine Tablets Due to Out-of-Specification Assay
FDA (Drugs) · 2015-10-21
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateOhm Allergy Relief Loratadine Recalled for Out-of-Specification Assay
FDA (Drugs) · 2015-10-21
- ModerateLoratadine-D Extended-Release Tablets Recalled for Failed Moisture Limits
FDA (Drugs) · 2021-11-03
- ModerateOhm Laboratories Recalls Loratadine Tablets for Out-of-Specification Assay
FDA (Drugs) · 2015-10-21
- LowOhm Recalls Loratadine Tablets Due to Out-of-Specification Assay
FDA (Drugs) · 2015-06-24
- ModerateOhm Recalls Up&Up Loratadine Tablets for Out-of-Specification Assay
FDA (Drugs) · 2015-10-21
- ModerateOhm Laboratories Recalls Loratadine Tablets Due to Out-of-Specification Assay
FDA (Drugs) · 2015-10-21