CLASS III Drug recall · Reported 24 Jun 2015 · FDA Enforcement Report
Loratadine Orally Disintegrating Tablets USP, 10 mg recalled
Ohm Laboratories is recalling Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24, distributed nationwide in the US. The recall was initiated on 4 May 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-1142-2015
- FDA event ID
- 71334
- Recalling firm
- Ohm Laboratories, North Brunswick, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 May 2015
- FDA classified
- 18 Jun 2015
- Reported
- 24 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 4 May 2015 | Recall initiated by company | |
| 18 Jun 2015 | Classified by FDA | +45 days |
| 24 Jun 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
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)
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?
Lot #: 2625094, Exp 06/2016
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.
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 |