CLASS III Drug recall · Reported 15 May 2013 · FDA Enforcement Report
Liothyronine Sodium Tablets, USP, 5 mcg recalled by L. Perrigo
L. Perrigo is recalling Liothyronine Sodium Tablets, USP, 5 mcg, distributed nationwide in the US. The recall was initiated on 12 Mar 2013 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-318-2013
- FDA event ID
- 64729
- Recalling firm
- L. Perrigo, Allegan, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Mar 2013
- FDA classified
- 9 May 2013
- Reported
- 15 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 12 Mar 2013 | Recall initiated by company | |
| 9 May 2013 | Classified by FDA | +58 days |
| 15 May 2013 | 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
Failed Impurities/Degradation Specifications: 3 month stability testing.
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
Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: 3 month stability testing.
Which lots are affected?
12K714 exp. 12/13, 12K715 exp. 12/13
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 L. Perrigo
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg recalledExchange Select Aller Ease | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy Aller-fex, Fexofenadine Hydrochloride Tablets, 180 mg recalledKirkland Signature Aller Fex | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride recalledBerkley Jensen Allergy Relief | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy, Fexofenadine Hydrochloride Tablets, 180 mg recalledBasic Care Allergy | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine recalled | L. Perrigo | Potency & Assay | Nationwide |
Other Liothyronine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 5 mcg recalledLiothyronine Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP, 25 mcg recalledLiothyronine Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP, 5 mcg recalledLiothyronine Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 25 mcg recalled by Mayne Pharma | Mayne Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 5 mcg recalledLiothyronine Sodium | SigmaPharm Laboratories | Other | Nationwide |