CLASS III Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Frovatriptan Succinate Tablets, 2.5mg recalled by Par Pharmaceutical
Par Pharmaceutical is recalling Frovatriptan Succinate Tablets, 2.5mg, distributed nationwide in the US. The recall was initiated on 10 Feb 2020 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-0843-2020
- FDA event ID
- 84912
- Recalling firm
- Par Pharmaceutical, Chestnut Ridge, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Feb 2020
- FDA classified
- 13 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
Timeline
| 10 Feb 2020 | Recall initiated by company | |
| 13 Feb 2020 | Classified by FDA | +3 days |
| 19 Feb 2020 | 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
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Product as listed by the FDA
Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Which lots are affected?
Lot Number: 9698818; labeled expiration AUG 2022; actual expiration APR 2022
Where was it sold?
Nationwide in the USA
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 Par Pharmaceutical
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | BusPIRone Hydrochloride Tablets, USP 7.5 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Tablets, USP 1 mg recalled by Par Pharmaceutical | Par Pharmaceutical | Potency & Assay | NY |
| Drug | CLASS III | PrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisone | Par Pharmaceutical | Other | Nationwide |
| Drug | CLASS I | Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate Mofetil | Par Pharmaceutical | Particulate Matter | Nationwide |
| Drug | CLASS III | Pramipexole dihydrochloride extended release tablets, 0.75 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide |
Other Frovatriptan recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Frovatriptan Succinate Tablets 2.5mg recalledFrovatriptan Succinate | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |