CLASS II Drug recall · Reported 5 Apr 2023 · FDA Enforcement Report
Calcitonin Salmon Nasal Spray recalled by Endo Pharmaceuticals
Endo Pharmaceuticals is recalling Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200, distributed nationwide in the US. The recall was initiated on 2 Mar 2023 and the FDA has classified it as Class II.
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-0475-2023
- FDA event ID
- 91802
- Recalling firm
- Endo Pharmaceuticals, Malvern, PA
- Brand
- Calcitonin Salmon
- Manufacturer
- Par Health USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2023
- FDA classified
- 24 Mar 2023
- Reported
- 5 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 2 Mar 2023 | Recall initiated by company | |
| 24 Mar 2023 | Classified by FDA | +22 days |
| 5 Apr 2023 | Published in enforcement report | +12 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 and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results 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
Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Is Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 recalled?
Yes. Endo Pharmaceuticals recalled Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 on 2 Mar 2023. The recall is Class II and its status is Terminated. Recall number D-0475-2023.
Why was it recalled?
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Which lots are affected?
Lot #: 34770301, exp. date Mar-23; 34770401, exp. date May-23; 12981201, exp. date Nov-23; 13037201, exp. date Dec-23; 13037301, 13647801, exp. date Feb-24; 13722101, exp. date Mar-24; 13980101, 13980001, exp. date Apr-24; 14461701, 14461801, exp. date Jul-24; 14706201, exp. date Aug-24; 14935601, exp. date Oct-24; 5500131A, 5500132A, exp. date Mar-25
Where was it sold?
Nationwide in the USA and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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 Endo Pharmaceuticals
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets recalledClonazepam | Endo Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS I | robaxin-750 (methocarbamol tablets, USP), 750 mg recalled | Endo Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Edex (alprostadil for injection) 10mcg recalled by Endo PharmaceuticalsEdex | Endo Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS III | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg recalled | Endo Pharmaceuticals | Other | Nationwide |
Other Calcitonin Salmon recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcitonin Salmon (synthetic origin) Nasal Spray recalled by ApotexCalcitonin Salmon | Apotex | Foreign Material | Nationwide |