Food, drugs, devices › Amneal Pharmaceuticals, Inc.
Drug recall: Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed
FDA enforcement event 84073 is a drug recall by Amneal Pharmaceuticals, Inc. of Brookhaven, NY, initiated 16 Oct 2019 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 22% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 9 Nov 2020. Initiation: voluntary: firm initiated. Amneal Pharmaceuticals, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Amneal Pharmaceuticals, Inc., Brookhaven, NY.
Reason for recall
"Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits."
Distribution
"Recalled product was distributed to retailers and wholesalers who may have further distribute the product."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0321-2020 | Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3 | 2460 cartons/3 blister cards/10 capsules each | Class III | Terminated | 20 Nov 2019 |
Context
Other enforcement events for Amneal Pharmaceuticals, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Nov 2019 | Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180- | Drug | Class II | 5 |
| 24 Sep 2019 | Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ ND | Drug | Class III | 1 |
| 18 Jul 2019 | Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08) | Drug | Class III | 1 |
| 25 Sep 2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Am | Drug | Class III | 2 |
All 5 events for Amneal Pharmaceuticals, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Recalled product was distributed to retailers and wholesalers who may have further distribute the product."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Nov 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.