CLASS II Drug recall · Reported 1 Aug 2018 · FDA Enforcement Report
Unit Dose Valsartan Tablets, USP, 80 mg recalled
Major Pharmaceuticals is recalling Unit Dose Valsartan Tablets, USP, 80 mg, distributed nationwide in the US. The recall was initiated on 18 Jul 2018 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-0966-2018
- FDA event ID
- 80557
- Recalling firm
- Major Pharmaceuticals, Livonia, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2018
- FDA classified
- 20 Jul 2018
- Reported
- 1 Aug 2018
- Type
- N/A
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 18 Jul 2018 | Recall initiated by company | |
| 20 Jul 2018 | Classified by FDA | +2 days |
| 1 Aug 2018 | 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
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
Where it was distributed
Nationwide.
Questions about this recall
Is Unit Dose Valsartan Tablets, USP, 80 mg recalled?
Yes. Major Pharmaceuticals recalled Unit Dose Valsartan Tablets, USP, 80 mg on 18 Jul 2018. The recall is Class II and its status is Terminated. Recall number D-0966-2018.
Why was it recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
Major Label Unit Dose 10 x 10 Cartons 80 mg Item # 302086. Lot# T-01270 (Expiry: 7/18). Lot# T-01466 (Expiry: 7/18). Lot# T-01500 (Expiry:2/19). Lot# T-01596 (Expiry: 2/19). Lot# T-01625 (Expiry: 2/19). Lot# T-01712 (Expiry: 2/19). Lot# T-01795 (5/19). Lot# T-01807 (Expiry: 5/19).
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 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 Major Pharmaceuticals
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg 0150 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 50 mcg 050 mg) dose blisters recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg 0125 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg 0112 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 25 mcg 025 mg) dose blisters recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
Other Unit dose valsartan recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Unit Dose Valsartan Tablets recalled by Major Pharmaceuticals | Major Pharmaceuticals | Potency & Assay | Nationwide |