URGENT VOLUNTARY RECALL: Pharmacy Level, August 05, 2026
- HOPE Clinic
- Aug 10
- 5 min read
Updated: 6 days ago
Levothyroxine Sodium Tablets USP 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg
Accord Healthcare, Inc. (“Accord Healthcare”) is voluntarily recalling Multiple lots of Levothyroxine Sodium Tablets USP, at the Pharmacy Level.
This recall is being initiated because out of specification results were observed during long-term stability testing of Levothyroxine Sodium Tablets USP 25 mcg, 50 mcg and 137 mcg. The out of specification results were observed during assay testing conducted on multiple lots of Levothyroxine Sodium Tablets.
The assay content of Levothyroxine Sodium Tablets for lots D2401833 (25 mcg, 94.4% at 21 months), D2401927 (25 mcg, 94.3% at 21 months), D2401834 (50 mcg, 94.6% at 21 months), D2401982 (50 mcg, 93.8% at 20 months) and D2402127 (137 mcg, 94.7% at 20 months) were observed to be below the approved specification range of 95.0% to 105.0% set forth on the label. This means that the observed level of active ingredients in the product was below the approved specification.
These results may affect the efficacy of the medication. As patient safety is the highest priority, Accord Healthcare is taking immediate action to recall the affected product lots.
In addition, as a precautionary measure and to further mitigate any potential risk, Accord Healthcare has also included other lots with the same expiry period in the recall. These additional product strengths include Levothyroxine Sodium Tablets USP 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg.
A cumulative list of all affected lots included in this recall is provided in the table below.
Please examine your inventory of Accord Healthcare’s Levothyroxine Sodium Tablets USP 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg for the below listed lot numbers carefully.
The recalled product can be identified by the strength, package size, NDC number, lot number, and expiration date listed below. Please also refer to the enclosed product labels included with this recall notification for identifying the recalled product.
Levothyroxine Sodium Tablets USP | ||||||
Strength | Bottle Pack size | Product NDC | Lot No. | Expiry Date | Product Shipment Dates | |
25 mcg | 1000 Tablets | 16729-447-17 | D2401927 | 08/31/2026 | 03/05/2025 - 04/14/2025 | |
25 mcg | 1000 Tablets | 16729-447-17 | D2401833 | 08/31/2026 | 02/14/2025 - 03/26/2025 | |
25 mcg | 1000 Tablets | 16729-447-17 | D2402551 | 11/30/2026 | 04/14/2025 - 04/30/2025 | |
25 mcg | 1000 Tablets | 16729-447-17 | D2402552 | 11/30/2026 | 04/30/2025 - 05/21/2025 | |
25 mcg | 1000 Tablets | 16729-447-17 | D2500220 | 12/31/2026 | 05/21/2025 - 06/11/2025 | |
25 mcg | 1000 Tablets | 16729-447-17 | D2500223 | 01/31/2027 | 06/11/2025 - 07/24/2025 | |
50 mcg | 1000 Tablets | 16729-448-17 | D2401834 | 08/31/2026 | 02/11/2025 - 02/20/2025 | |
Strength | Bottle Pack size | Product NDC | Lot No. | Expiry Date | Product Shipment Dates | |
50 mcg | 1000 Tablets | 16729-448-17 | D2401982 | 08/31/2026 | 02/19/2025 - 03/05/2025 | |
50 mcg | 1000 Tablets | 16729-448-17 | D2402584 | 11/30/2026 | 03/05/2025 - 03/19/2025 | |
50 mcg | 1000 Tablets | 16729-448-17 | D2402585 | 11/30/2026 | 03/18/2025 - 04/03/2025 | |
50 mcg | 1000 Tablets | 16729-448-17 | D2402586 | 11/30/2026 | 04/01/2025 - 04/10/2025 | |
50 mcg | 1000 Tablets | 16729-448-17 | D2402588 | 11/30/2026 | 04/23/2025 - 04/30/2025 | |
50 mcg | 1000 Tablets | 16729-448-17 | D2402587 | 11/30/2026 | 04/10/2025 - 04/23/2025 | |
50 mcg | 1000 Tablets | 16729-448-17 | D2402589 | 11/30/2026 | 04/30/2025 - 05/08/2025 | |
75 mcg | 1000 Tablets | 16729-449-17 | D2402016 | 08/31/2026 | 03/05/2025 - 03/28/2025 | |
75 mcg | 1000 Tablets | 16729-449-17 | D2402017 | 08/31/2026 | 03/05/2025 - 04/10/2025 | |
88 mcg | 1000 Tablets | 16729-450-17 | D2401813 | 08/31/2026 | 02/14/2025 - 04/23/2025 | |
88 mcg | 1000 Tablets | 16729-450-17 | D2401814 | 08/31/2026 | 03/11/2025 - 05/21/2025 | |
88 mcg | 1000 Tablets | 16729-450-17 | D2500200 | 12/31/2026 | 05/21/2025 - 06/18/2025 | |
88 mcg | 1000 Tablets | 16729-450-17 | D2500219 | 12/31/2026 | 06/18/2025 - 07/24/2025 | |
100 mcg | 90 Tablets | 16729-451-15 | D2402186 | 09/30/2026 | 03/13/2025 - 06/13/2025 | |
100 mcg | 1000 Tablets | 16729-451-17 | D2402019 | 08/31/2026 | 03/04/2025 - 03/25/2025 | |
100 mcg | 1000 Tablets | 16729-451-17 | D2402094 | 09/30/2026 | 03/25/2025 - 04/03/2025 | |
100 mcg | 1000 Tablets | 16729-451-17 | D2500022 | 12/31/2026 | 04/23/2025 - 05/08/2025 | |
100 mcg | 1000 Tablets | 16729-451-17 | D2500023 | 12/31/2026 | 05/07/2025 - 06/04/2025 | |
100 mcg | 1000 Tablets | 16729-451-17 | D2500021 | 12/31/2026 | 04/04/2025 - 04/23/2025 | |
112 mcg | 1000 Tablets | 16729-452-17 | D2402443 | 10/31/2026 | 03/12/2025 - 04/23/2025 | |
112 mcg | 1000 Tablets | 16729-452-17 | D2402444 | 10/31/2026 | 03/04/2025 - 05/14/2025 | |
112 mcg | 1000 Tablets | 16729-452-17 | D2402445 | 10/31/2026 | 05/14/2025 - 07/02/2025 | |
125 mcg | 1000 Tablets | 16729-453-17 | D2401983 | 08/31/2026 | 02/11/2025 - 03/12/2025 | |
125 mcg | 1000 Tablets | 16729-453-17 | D2402640 | 11/30/2026 | 04/02/2025 - 04/30/2025 | |
125 mcg | 1000 Tablets | 16729-453-17 | D2402641 | 11/30/2026 | 04/30/2025 - 06/11/2025 | |
125 mcg | 1000 Tablets | 16729-453-17 | D2500224 | 01/31/2027 | 06/11/2025 - 10/06/2025 | |
137 mcg | 90 Tablets | 16729-454-15 | D2402125 | 09/30/2026 | 02/18/2025 - 06/05/2025 | |
137 mcg | 90 Tablets | 16729-454-15 | D2402126 | 09/30/2026 | 02/24/2025 - 09/03/2025 | |
137 mcg | 90 Tablets | 16729-454-15 | D2402127 | 09/30/2026 | 09/03/2025 - 11/10/2025 | |
137 mcg | 1000 Tablets | 16729-454-17 | D2402523 | 11/30/2026 | 02/12/2025 - 06/25/2025 | |
137 mcg | 1000 Tablets | 16729-454-17 | D2402524 | 11/30/2026 | 06/25/2025 - 08/06/2025 | |
150 mcg | 1000 Tablets | 16729-455-17 | D2402195 | 09/30/2026 | 04/22/2025 - 06/04/2025 | |
150 mcg | 1000 Tablets | 16729-455-17 | D2402196 | 09/30/2026 | 06/04/2025 - 07/16/2025 | |
150 mcg | 1000 Tablets | 16729-455-17 | D2402197 | 09/30/2026 | 07/16/2025 - 09/17/2025 | |
175 mcg | 90 Tablets | 16729-456-15 | D2402642 | 11/30/2026 | 06/18/2025 - 11/05/2025 | |
175 mcg | 1000 Tablets | 16729-456-17 | D2401832 | 08/31/2026 | 01/28/2025 - 03/05/2025 | |
175 mcg | 1000 Tablets | 16729-456-17 | D2402525 | 11/30/2026 | 03/04/2025 - 04/23/2025 | |
175 mcg | 1000 Tablets | 16729-456-17 | D2402527 | 11/30/2026 | 06/11/2025 - 07/23/2025 | |
175 mcg | 1000 Tablets | 16729-456-17 | D2402526 | 11/30/2026 | 04/25/2025 - 06/13/2025 | |
175 mcg | 1000 Tablets | 16729-456-17 | D2402644 | 11/30/2026 | 09/18/2025 - 11/19/2025 | |
175 mcg | 1000 Tablets | 16729-456-17 | D2402643 | 11/30/2026 | 07/23/2025 - 10/01/2025 | |
200 mcg | 90 Tablets | 16729-457-15 | D2402430 | 10/31/2026 | 04/01/2025 - 07/11/2025 | |
200 mcg | 90 Tablets | 16729-457-15 | D2402431 | 10/31/2026 | 03/19/2025 - 11/05/2025 | |
200 mcg | 1000 Tablets | 16729-457-17 | D2402432 | 10/31/2026 | 03/18/2025 - 06/25/2025 | |
200 mcg | 1000 Tablets | 16729-457-17 | D2500180 | 12/31/2026 | 06/25/2025 - 09/10/2025 | |
300 mcg | 90 Tablets | 16729-458-15 | D2402337 | 10/31/2026 | 04/02/2025 - 12/18/2025 | |
Pharmacy - Please perform the following activities:
Examine your inventory immediately for the listed lot numbers of Levothyroxine Sodium Tablets USP 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg.
Immediately discontinue distribution of the recalled Lot numbers of Accord Healthcare’s Levothyroxine Sodium Tablets USP 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg.
Promptly complete the attached Product Recall Response Form and reply even if you have NO Product to return.
If you do have product to return, complete the attached Product Recall Response Form, quarantine the stock and follow the instructions given on the recall response form.
If you have further distributed this lot number to other retailers, please immediately contact them and advise them of the recall and have them return their outstanding recalled stock to you. Return this stock as per the instructions on the attached Product Recall Response Form.
Your assistance is appreciated and necessary to prevent any potential health risk to the consumer.
Accord is working with Inmar Inc. to complete this recall. This recall is being made with the knowledge of the Food & Drug Administration. Your cooperation and prompt response to this notice is much appreciated.
Please complete and return the enclosed “PRODUCT RECALL RESPONSE FORM” as soon as possible, but no later than five business days from receipt of this letter.
Completed Product Recall Response form should be emailed, or sent via FAX to INMAR,
Attn: Inmar Rx Solutions, 3845 Grand Lakes Way, Grand Prairie, TX 75050. INMAR Email: rxrecalls@inmar.com. FAX: 1-817-868-5362.
If you have any questions about the logistics for returning affected lot or other issues, please call Recall Services at 1-855-423-5043, Monday – Friday (excluding holidays), 9am to 5 pm EST.
INMAR will send you a Return Goods Authorization and shipping label. Appropriate credit for the returned product plus handling and shipping expenses will be issued to you upon receipt of the recalled product with the completed Return Goods Authorization. All recalled products returned without a Return Goods Authorization may delay the issuance of your credit.
We appreciate your assistance in this matter.
Sincerely,
Sabita Nair, RAC, ASQ-CPGP
Vice President – Regulatory Affairs Accord Healthcare, Inc.
8041 Arco Corporate Drive, Suite 200
Raleigh, NC 27617, USA
Click below to view the official letter from the Manufacturer: