CLASS III Drug recall · Reported 21 Oct 2015 · FDA Enforcement Report
Ohm Loratadine Orally Disintegrating Tablets recalled
Ohm Laboratories is recalling Ohm Loratadine Orally Disintegrating Tablets, USP, distributed nationwide in the US. The recall was initiated on 28 Jul 2015 and the FDA has classified it as Class III.
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-0032-2016
- FDA event ID
- 71973
- Recalling firm
- Ohm Laboratories, North Brunswick, NJ
- Brand
- Allergy Relief
- Manufacturer
- Ohm Laboratories Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Jul 2015
- FDA classified
- 15 Oct 2015
- Reported
- 21 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 28 Jul 2015 | Recall initiated by company | |
| 15 Oct 2015 | Classified by FDA | +79 days |
| 21 Oct 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Which lots are affected?
Batch Numbers: 2544486, Exp 7/31/2016; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016
Where was it sold?
Nationwide.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
20 other products · FDA event 71973This product is part of a recall event; the main page for the event is Leader Loratadine Orally Disintegrating Tablets recalled.
More recalls from Ohm Laboratories
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Premier Value Loratadine Orally Disintegrating Tablets recalled | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Equaline Original Prescription Strength recalled by Ohm Laboratories | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Rite Aid Pharmacy loratadine orally disintegrating tablets recalled | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Cvs Pharmacy, Original Prescription Strength recalled | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Up&Up loratadine orally disintegrating tablets recalled | Ohm Laboratories | Potency & Assay | Nationwide |
Other Loratadine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Loratadine-D Extended-Release Tablets (Loratadine recalledLoratadine And Pseudoephedrine Sulfate | SUN Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS III | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate recalledKirkland Signature Allerclear D 24 Hr | SUN Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS II | Children's Loratadine Oral Solution USP, 5 mg recalledChildrens Loratadine | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Non-Drowsy 24 Hour Formula Allergy Relief recalled by Ohm LaboratoriesLoratadine And Pseudoephedrine Sulfate | Ohm Laboratories | Other | 4 states |
| Drug | CLASS II | Loratadine Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |