Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported July 10, 2019
Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Amneal Pharmaceuticals, Inc. recalled Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottl… - a low-severity action.
Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottl… was recalled by Amneal Pharmaceuticals, Inc. in July 10, 2019. Reason: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.. Check the official notice for the remedy. Verify recall #D-1438-2019 with the FDA Drug before acting.
The recall
Amneal Pharmaceuticals, Inc. issued this low-severity FDA Drug recall-Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets..
- Low
- severity level
- 19K units
- affected scope
- Class III
- classification
- July 10, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1438-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1438-2019) was formally reported on July 10, 2019, with the manufacturer initiating the action on September 25, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Amneal Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Brookhaven, NY. Federal records list the affected scope as 19104 units.
The documented reason for this recall is: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19104 units
Related Recalls
6
5 from same agency
Product description
Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01
Reason for recall
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1438-2019 |
| Date reported | July 10, 2019 |
| Date initiated | September 25, 2017 |
| Recalling firm | Amneal Pharmaceuticals, Inc. |
| Firm location | Brookhaven, NY |
| Affected scope | 19104 units |
| Distribution | Nationwide within the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1438-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01. Recalled by Amneal Pharmaceuticals, Inc.. Units affected: 19104 units.
Why was this product recalled? ▼
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 10, 2019. Severity: Low. Recall number: D-1438-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1438-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 10, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.