FDA Drug recall D-0035-2021
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta,…
- FDA Drug
- Class I
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class I recall of NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta,… by Acella Pharmaceuticals, citing subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0035-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-09-17 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Acella Pharmaceuticals |
| Distribution | US |
Product
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01
Reason
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Identifiers
| ndc | 42192-327-01 |
|---|---|
| ndc | 42192-327-30 |
| ndc | 42192-327-90 |
| ndc | 42192-329-01 |
| ndc | 42192-329-30 |
| ndc | 42192-329-10 |
| ndc | 42192-329-90 |
| ndc | 42192-330-01 |
| ndc | 42192-330-30 |
| ndc | 42192-330-10 |
| ndc | 42192-330-90 |
| ndc | 42192-331-01 |
| ndc | 42192-331-30 |
| ndc | 42192-331-10 |
| ndc | 42192-331-90 |
| ndc | 42192-328-01 |
| ndc | 42192-328-30 |
| ndc | 42192-328-90 |
| code_info | Lot #: M327E19-1 Exp. 10/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class III · 2022-12-07 · Acella Pharmaceuticals - Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufact…
FDA Drug · Class III · 2022-11-30 · Acella Pharmaceuticals
All Acella Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0035-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.