CLASS III Drug recall · Reported 17 Oct 2018 · FDA Enforcement Report
Amlodipine Besylate recalled by InvaGen Pharmaceuticals
InvaGen Pharmaceuticals is recalling Amlodipine Besylate USP, distributed nationwide in the US. The recall was initiated on 3 Oct 2018 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-0012-2019
- FDA event ID
- 81099
- Recalling firm
- InvaGen Pharmaceuticals, Hauppauge, NY
- Brand
- Amlodipine Besylate
- Manufacturer
- Cipla USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Oct 2018
- FDA classified
- 11 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 3 Oct 2018 | Recall initiated by company | |
| 11 Oct 2018 | Classified by FDA | +8 days |
| 17 Oct 2018 | 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
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
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
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15
Where it was distributed
Nationwide with the United States
Questions about this recall
Why was it recalled?
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Which lots are affected?
Lot #: GG80218, Exp. 12/2019
Where was it sold?
Nationwide with the United States
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 InvaGen Pharmaceuticals
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets recalledVigabatrin | InvaGen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Gabapentin Tablets USP, 600 mg recalled by InvaGen PharmaceuticalsGabapentin | InvaGen Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Testosterone Topical Solution 30mg of testosterone per pump recalledTestosterone | InvaGen Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 200 mg/mL recalledTestosterone Cypionate | InvaGen Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 2000 mg/ (200 mg/mL) recalledTestosterone Cypionate | InvaGen Pharmaceuticals | Particulate Matter | Nationwide |
Other Amlodipine recalls
All 81| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalledAmlodipine Besylate And Benazepril Hydrochloride | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin PharmaceuticalsAmlodipine Besylate | Lupin Pharmaceuticals | Potency & Assay | Nationwide |